FDA ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

  • Posted on: 14 February 2019
  • By: Shalini.Sharma

The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA.

On the illicit drugs front, worked to increase our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international mail facilities (IMFs). Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing FDA-regulated products and were pulled for FDA review indeed contained illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs.

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

  • Posted on: 4 February 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. The FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.

Nicox announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis

  • Posted on: 30 January 2019
  • By: PharmaTutor News

Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.  The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.

FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium

  • Posted on: 25 January 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.

FDA unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths

  • Posted on: 18 January 2019
  • By: Shalini.Sharma

The  number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017.  This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

  • Posted on: 17 January 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

FDA new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

  • Posted on: 9 January 2019
  • By: Shalini.Sharma

Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.

FDA new steps to promote innovations in medical devices that help advance patient safety

  • Posted on: 20 December 2018
  • By: Shalini.Sharma

Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. FDA is taking steps on two additional device programs: finalizing guidance on our existing Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).