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  • Shadow Pharma Venture Private Limited, Mumbai and Gplife Healthcare Private Limited, Surat have announced that the next generation Phytochemistry technology-based Nutraceutical formulations ACT- 12 and ACT - 13 have successfully cleared Phase II clinical trials for the treatment of COVID 19 positive hospitalized patients.

    The formulations were compared for its safety and clinical efficacy against standard of care in COVID 19 patients.

    60.0% of cases from Test Group showed PCR negativity compared to 40.0% in standard Group at Day 4. No Patient continued to remain Covid positive after the 10th day in the Test group and 7 Patients remained Covid positive after 10 days in the standard group. The IgG and IgM immunoglobulin levels were noticed to be higher demonstrating improved antibody functionality and thereby the immunomodulatory activity offered.

    Anti-inflammatory effect by Lowering LDH, CRP with improvement in SpO2 & Thrombocytopenia can reduces risk of lung fibrosis.


    Kiran Narasimha Pai (MBA IIM Calcutta), Advisor to Gplife Healthcare, said that “These results are among the best results for any Nutraceutical or Phytochemistry based formulation in the world for the treatment of COVID-19. If the same results with No mortality and 40% faster recovery rates can be replicated in a much larger Phase III trial, then we could be looking at the end of, at least, the severity of the COVID-19 pandemic."

    He further said, "Since these products have essentially very low side effects and are FSSAI approved, they can be started as an adjuvant treatment globally, almost immediately”.


    Prasad Kanitkar, Chief Technical Officer (CTO), Shadow Pharma added “These products and technologies are the outcome of putting Science and Nature together for the betterment of human beings and hope of life in ongoing pandemic.” He congratulated Dr. Shridhar Pandya Scientist and Director Gplife on making this research a reality at the exact time when the whole world needed it. Shadow Pharma Venture Pvt. Ltd. Mumbai has tied up with Gplife Health Care Pvt. Ltd. to commercialize its COVID 19 ACT 12 & ACT 13 Treatment Therapy and remaining Nutraceutical portfolio.

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  • COVAXIN vaccine shows remarkable immunogenicity and protective efficacy against SARS-CoV-2 (new coronavirus). It’s research name is BBV152 which an inactivated SARS-CoV-2 vaccine.

    Two doses vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques (divided into four groups equally). One group was administered with placebo, while three groups were immunized with 3 different vaccine candidates at 0 and 14 days. All the macaques were exposed to viral challenge 14 days after the 2nd dose. The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralizing antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey.

    No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group. Adverse events were not seen in animals immunized with a two-dose vaccination regimen.


    Genomic RNA (gRNA) was detected from nasal swab (NS) specimens of all animals in the placebo group from 1 to 7 DPI (Days Post-Infection). Viral clearance was observed in NS specimens of all the animals from the vaccinated group on 7 DPI. Subgenomic RNA (sgRNA) was detected in two of five animals at 3 DPI and one of five animals at 7 DPI of the placebo group.  sgRNA was detected in the NS sample of only one animal of the vaccinated group IV on 5 DPI.

    Neutralizing antibodies and IgG responses were observed from 3rd-week post-immunization in vaccinated groups. IgG titer rose in an increasing pattern with the highest response in group III. The presence of gRNA in NS was observed in the placebo group until 7 DPI. Vaccinated groups had no detectable gRNA in NS on 7 DPI indicating the ability of vaccine candidates to limit upper respiratory tract viral replication, which is a key factor determining the virus transmission.


    gRNA and sgRNA were not detected in the Bronchoalveolar lavage fluid from 5 DPI suggesting that vaccination hindered virus replication and enabled faster clearance from lower airway protecting the animals. gRNA was detected in multiple organs at necropsy in the placebo group, whereas it was found to be cleared in the vaccinated groups.

    Altogether this study demonstrates that a two-dose vaccination regimen using 3µg dose of the vaccine candidate with adjuvant induce a significant immune response and provide effective protection in animals challenged with SARS-CoV-2.

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  • The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate. 

    "We are excited about the potential of helping patients with AL amyloidosis who currently have no FDA-approved therapies for the treatment of their disease," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "The results from the Phase 3 ANDROMEDA study also provide preliminary evidence of DARZALEX FASPRO's potential to modify the organ damage that is a hallmark of this serious disease with high unmet needs and we look forward to collaborating with the agency in the review of the application."

    The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. The RTOR program aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR program does not guarantee or influence approvability of the supplemental application.


    The submission is also being reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies.

    AL amyloidosis is a life-threatening disorder that occurs when plasma cells in the bone marrow produce abnormal light chains, that form amyloid deposits, which build up in vital organs and eventually cause organ deterioration. The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, GI tract and nervous system. Diagnosis of AL amyloidosis is often delayed because patients present with non-specific symptoms that mimic other conditions, resulting in a poor prognosis. There are currently no FDA-approved therapies to treat this devastating disease. While AL amyloidosis is the most common type of amyloidosis, it remains a rare disease with an estimated 30,000 to 45,000 people living with the disease in the U.S. and Europe. Each year, an estimated 4,500 people develop AL amyloidosis in the U.S. alone.


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  • Doctors at the Krishna Institute of Medical Sciences (KIMS), one of India’s leading healthcare providers, have successfully performed India’s first-ever double lung transplant surgery on a Covid-19+ve patient, who was discharged from the hospital on Friday. The procedure was performed at the main branch of the hospital located at Hyderabad, and was led by Dr. Sandeep Attawar, who is considered a pioneer in heart and lung transplant surgeries in India.

    The patient, a Rizwan (Monu) 32-year-old man from Chandigarh, Punjab, was suffering from sarcoidosis that affected his lungs significantly, leading to fibrosis of the lungs. Condition of the patient deteriorated rapidly. A double lung transplant was the only permanent option for cure. The situation worsened when the patient contracted coronavirus while awaiting for his double lung transplant. This worsened matters as it increased his oxygen requirement from 15 liters/minute to 50 liters/min for the past 8 weeks.

    Commenting on the procedure, Dr. Sandeep Attawar, Thoracic Organ Transplantation Surgeon, KIMS Heart & Lung Transplant Institute, KIMS Hospitals said, “The patient was a severe case of lung sarcoidosis, and Covid-19 virus only complicated the precarious lung condition. Fortunately, a match to his lungs was found in a person declared braindead in Kolkata, and the harvested lungs were airlifted to Hyderabad to save the life of the patient. The procedure was complex and had little scope for errors; and only a timely transplant of lungs helped save the patient. What is more important is that good outcomes are difficult to achieve as these patients are extremely sick, under nourished and bed ridden before the transplant. Post discharge, he will need close monitoring, bio bubble environment & careful drug control for 6 weeks at least.

    Dr. Sandeep Attawar, is the most experienced heart and lung transplant surgeons in the country. A veteran in the field of transplant surgeries with over 24-years’ experience, Dr. Attawar has to date performed over 12,000 heart surgeries, and has over 250 transplant surgeries for lungs, heart, and artificial heart implants (LVAD) to his credit.


    The prevailing scenario around the world in general and India is compelling patients to stay indoors for a prolonged period. While people are ignoring/neglecting certain ailments and not seeking medical care at the right time, prolonged neglect could result into complex ailments. Hence, it is suggested that people stay aware of the symptoms of possible ailments they could contract and respond to it with medical care.

  • Scientists develop canister bag

    The world was already struggling with some highly infectious diseases like tuberculosis, influenza, when COVID-19 struck. It is a highly transmissible disease and spreads within fraction of a second. Infected patient’s respiratory secretions are highly contagious and there are very high chances of spread of disease through this.

    In a development that could bring huge relief for healthcare professionals, Sree Chitra Institute of Medical Sciences in Thiruvananthapuram has developed canister bags, lined with super-absorbent material containing an effective disinfectant. The bag has been named AcryloSorb. The method is meant for safe handling and disposal of respiratory secretions of patients in Intensive Care Units as well as of those admitted in wards with copious respiratory secretions.

    “Disposal of respiratory secretions of patients suffering from highly contagious diseases such as COVID-19, tuberculosis (TB) and influenza, poses a high risk of infection among healthcare workers. In the canister bags, secretions are sucked into bottles or canisters using vacuum line and discarded through the waste fluid disposal system after subjecting to decontamination process. There is a high risk of contamination during the handling that poses a high risk to health workers. The disposal needs well-equipped sluice rooms with disinfection facilities. The canister bags can absorb 500 ml of secretions and solidify them immediately. And the presence of the disinfectant makes the whole system decontaminated within no time,” says a press statement issued by the institute.


    “ Disposal of respiratory secretions of patients suffering from highly contagious diseases such as COVID-19, tuberculosis (TB) and influenza, poses a high risk of infection among healthcare workers.

    The product has been tested as per international standards and the linear structure has a patented design, the institute states. Field trials of the in-house designed suction canister liner bags are being conducted at the institute. It’s expected to bring the bag to the market at a cost of Rs 100 per bag.


    Sree Chitra Institute claims the canister bag allows easy, spill-proof disposal of the biomedical waste. The press release reads, “Solidification and disinfection inside the bags eliminate the risk of secondary infections by avoiding spilling, and aerosol formation. Canister bags are enclosed in a customizable sealer bag which can pack it as spill-proof decontaminated biomedical waste disposable through incineration.”

    The team that developed the technology include Dr Manju, S, Dr Manoj Komath, Dr Asha Kishore (who is also the Institute Director) and Dr Ajay Prasad Hrishi who are biomaterial scientists and clinicians - The institute has transferred the know-how of the bags to Romsons Scientific and Surgical Private Limited in Uttar Pradesh that produces medical devices.

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  • Strides Pharma Science Limited (Strides) stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the approval of the United States Food & Drug Administration (USFDA) for Prednisone Tablets USP, 1 mg. These tablets are a generic version of Schering Corporation’s Meticorten Tablets, 1 mg.

    As per the IQVIA MAT July 2020 figures, the US market ranges up to USD 12 million for Prednisone Tablets USP, 1 mg. According to the company’s press release, the manufacturing of the tablet will take place at the flagship facility of the company at Bengaluru. The tablets will be sold in the US market by Strides Pharma Inc. 

    Recently on August 21, 2020, Strides Pharma Science Limited got the USFDA approval for Ursodiol Tablets USP, 250 mg and 500 mg also. During February, Strides’ wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, signed a comprehensive asset transfer and licensing agreement with Pharmaceutics International, Inc. to obtain 18 ANDAs from the company for the US market. Strides aim to expand its niche offerings significantly on its front end, that will lead to multi fold growth in the upcoming years.


    As per the consolidated unaudited financial reports of the company for the quarter ended June 30, 2020, the company’s total income was INR 7,941.02 million as compared to the INR 6,960.52 million of the corresponding quarter of the previous year. The profit before tax for the above-mentioned quarter stands at INR 1,051.25 million which is much higher than INR 248.84 million of the corresponding quarter of the previous year.

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  • Roche announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.

    BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.

    “Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare,” said Thomas Schinecker, CEO Roche Diagnostics. “This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.”


    The cobas BKV Test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. Along with the previously approved cobas® EBV and CMV Tests, the cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.

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  • Xu Yu, MD, Ragon Institute group leader, recently published a study entitled “Distinct viral reservoirs in individuals with spontaneous control of HIV-1,” in Nature. Yu’s lab, in collaboration with Ragon group geaders Mathias Lichterfeld, MD, PhD and Mary Carrington, PhD, and Ragon Director, Bruce Walker, MD, found rare sequences of HIV DNA by analyzing billions of cells from 64 elite controllers (people living with HIV who suppress the virus naturally without the need for medication), and 41 individuals on antiretroviral drugs (ART).  Unlike ART-treated individuals, elite controllers’ viral reservoirs appear to be incapable of being reactivated. This likely helps the elite controllers maintain spontaneous, drug-free control of HIV and may represent a distinguishing feature for a functional cure of HIV infection.

    HIV affects more than 35 million people worldwide and can be effectively controlled, but not cured, with a daily regimen of ART. Upon infection, retroviruses like HIV place copies of their viral genetic material into cells’ genomes, creating viral reservoirs, sanctuaries where HIV persists despite ART, throughout the body. When a complete copy of the virus, or intact viral genome, is incorporated into a cell’s genome, it can be used to create new copies of HIV. For people living with HIV, this means that if they stop taking ART, the intact viral genomes previously integrated into the cells’ genomes start making new copies of the virus, leading to rapid viral rebound and disease progression. The HIV viral reservoir has remained a major obstacle to an HIV cure.

    Elite controllers’ immune systems use a T-cell mediated immune response to control the virus without medication, to the point that the virus is completely undetectable by standard assays. Understanding the interplay between their immune system and HIV may hold the key to helping the immune systems of people living with HIV to suppress the virus without daily treatment, achieving what is known as a functional cure


    Yu’s group studied the viral reservoir in elite controllers, using next-generation sequencing techniques to precisely map the locations of intact HIV genomes in the human genome. They found that in elite controllers, HIV was often found in locations of the genome that researchers call gene deserts. In these inactive parts of the human genome, human DNA is never turned on, and HIV cannot be effectively expressed but remains in a “blocked and locked” state. This means that HIV is locked in the cell’s genome, and the viral genome is blocked from being used to create more viruses and is therefore incapable of causing disease.

    “This positioning of viral genomes in elite controllers,” Yu, says, “is highly atypical, as in the vast majority of people living with HIV-1, HIV is located in the active human genes where viruses can be readily produced.”


    When the authors collected cells from elite controllers and infected them with HIV in the lab, they found the virus integrated into active sites in the cell genomes, not in the inactive gene deserts. This suggests that the elite controllers’ unique viral reservoirs may be a result of their HIV-suppressing T cell response eliminating intact viral genomes from active sites.

    If researchers are able to identify which viral reservoirs can make new copies of the virus after treatment stops, it may help them to target a treatment against the active, or rebound-competent, reservoirs. This study suggests that if researchers can activate the kind of T cell immunity that is present in elite controllers, they may be able to eliminate rebound-competent viral reservoirs in people living with HIV, achieving a functional cure. The remaining viral DNA, located in non-active parts of the human genome, could be allowed to exist without causing disease. 

    “NHLBI is interested in understanding how the immune systems of some people living with HIV naturally control their infection without medication,” said Keith Hoots, M.D., director of the Division of Blood Diseases and Resources at the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, and a veteran HIV researcher himself. “What happens with these individuals, whom we call elite controllers, may shed light on an HIV-1 cure and also help us understand how a person with HIV might control virus and avoid HIV-associated comorbidities.”

    Yu’s group had one more finding: one of their elite controller participants had no intact HIV found in over 1.5 billion cells analyzed. This raises the possibility that a “sterilizing cure” of HIV, in which the participant’s immune system has removed all intact HIV genomes from the body, may be achieved naturally in extremely rare instances.

    This project was supported by the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Drug Abuse, the National Institutes of Health, the Mark and Lisa Schwartz Family Foundation, the Ragon Institute of MGH, MIT and Harvard, the Bill & Melinda Gates Foundation, and the Foundation for AIDS Research (amfAR).

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  • Baxter International Inc a global innovator in renal care, announced the U.S. Food and Drug Administration (FDA) has granted the De Novo application for Theranova, the company’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa). These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.

    By granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space. In fact, less than 1% of devices granted marketing authorization under De Novo have been for the care of patients with kidney failure since the pathway’s inception in 1997.

    HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane required. Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off® membrane combines high permeability and selectivity for uremic toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment2,3. This unique cut-off and high retention onset profile expands clearance, allowing for filtration closer to that of the natural kidney.


    "U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova," said Gavin Campbell, general manager of Baxter's U.S. Renal Care business. "Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the U.S. to ensure healthcare providers can also realize the full value of this therapy for their patients on HD."

    To date, over 90 independent and Baxter-led or sponsored studies have been conducted on HDx therapy enabled by Theranova. The studies evaluated a range of clinical and quality-of-life measures, including the ability to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.


    "Individually, the side effects from standard HD, which patients typically undertake three days a week, four hours per day, may seem manageable. However, the chronic effects of treatment accumulate and over time, cause some patients to give up on therapy," explained Mary Gellens, M.D., nephrologist and senior medical director at Baxter. "HDx therapy enabled by Theranova is a promising alternative to what is currently available because it delivers a filtration profile that is closer to the natural kidney."

    Due to the novel nature of Theranova, Baxter conducted a randomized controlled clinical study in the United States that evaluated the safety and efficacy of HDx therapy enabled by Theranova. During the study, as reported during the 2019 American Society of Nephrology Kidney Week, 172 hemodialysis patients received therapy with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (ELISIO-17H) over 24 weeks of treatment, with a primary efficacy endpoint measuring the reduction ratio of lambda (λ) free light chains at 24 weeks of treatment, while maintaining pre-dialysis serum albumin levels. Data from the study, which was just published in the Clinical Journal of the American Society of Nephrology (CJASN), found that expanded hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of large middle molecules, as exemplified by λ free light chains, as compared to a similarly sized high flux dialyzer while maintaining serum albumin levels7. Large middle molecules are a diverse group of uremic toxins that are believed to contribute to the high cardiovascular disease burden in end stage kidney disease8. Dialysis technologies available to date offer limited clearance of these molecules8. The ability to efficiently remove these large middle molecules provides dialysis patients with a new alternative therapy.

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  • Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. As we do so, we’re also taking proactive efforts to help ensure that in the future, drugs can be free from unsafe levels of these impurities from the start of production.

    Ensuring that drugs are safe, effective and high-quality is a critical part of FDA’s mission. In our continued efforts to be transparent and provide guidance to manufacturers on how to detect and prevent unacceptable levels of nitrosamine impurities, today we’re publishing our guidance Control of Nitrosamine Impurities in Human Drugs for immediate implementation. This guidance recommends steps, including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.

    There are many reasons why these impurities might appear in some drugs, and consequently many approaches to screening for and preventing the appearance of nitrosamines to help ensure drug quality and safety. The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged. Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.

    The most common nitrosamine impurity, N-nitrosodimethylamine (NDMA), is found at low levels in water and foods, including cured and grilled meats, dairy products and vegetables. The FDA and the international scientific community do not expect NDMA to cause harm when ingested at low levels. However, given the risk that genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time, manufacturers have recalled drugs with NDMA levels higher than the FDA’s recommended acceptable intake levels. Patients taking medications with potential nitrosamine impurities should not stop taking their medications and should talk with their health care professional about concerns and other treatment options.


    We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs. Protecting patients is the FDA’s highest priority, and we will continue to work with manufacturers and our international regulatory partners to investigate and definitively resolve this problem.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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