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- Read more about FDA took new steps to strengthen and modernize inspections for sterile injectable drugs
Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues.
- Read more about FDA and DoD formalize collaboration to advance medical products in support of American military personnel
U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.
- Read more about NPPA revises ceiling/retail prices of 68 scheduled formulations under DPCO 2013
The National Pharmaceutical Pricing Authority (NPPA) has fixed/revised ceiling/retail prices of 68 scheduled formulations under Drugs (Prices Control) Order, 2013 in related notification dated November 2, 2018.
- Read more about FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).
- Read more about High exposure to radio frequency radiation associated with cancer in male rats
The National Toxicology Program (NTP) concluded there is clear evidence that male rats exposed to high levels of radio frequency radiation (RFR) like that used in 2G and 3G cell phones developed cancerous heart tumors, according to final reports released . There was also some evidence of tumors in the brain and adrenal gland of exposed male rats. For female rats, and male and female mice, the evidence was equivocal as to whether cancers observed were associated with exposure to RFR. The final reports represent the consensus of NTP and a panel of external scientific experts who reviewed the studies in March after draft reports were issued in February.
- Read more about NIH to fund national data collection on new mothers with disabilities
The National Institutes of Health will fund the collection of information from women with disabilities who give birth in the United States to supplement the Pregnancy Risk Assessment Monitoring System (PRAMS).
- Read more about FDA announce Voluntary Recall of Irbesartan Tablets
ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level.
- Read more about Astrocytes regulate signal speeds of neurons: Study
The transmission speed of neurons fluctuates in the brain to achieve an optimal flow of information required for day-to-day activities, according to a National Institutes of Health study. The results, appearing in PNAS, suggest that brain cells called astrocytes alter the transmission speed of neurons by changing the thickness of myelin, an insulation material, and the width of gaps in myelin called nodes of Ranvier, which amplify signals.

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- Read more about Gut bacteria may control movement: Study
A new study puts a fresh spin on what it means to “go with your gut.” The findings, published in Nature, suggest that gut bacteria may control movement in fruit flies and identify the neurons involved in this response. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
- Read more about EMA Working with stakeholders to improve availability of medicines in the EU
The task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid shortages of medicines.