Regulatory Authority Actions

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

Can a commitment to limit prices to ensure patient access to important new medicines regain public trust and confidence in the biopharmaceutical industry?

The approval comes after the results of a clinical trial that showed 61% of patients had a response lasting six months or longer.

The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.

The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

While falling short of the 2018 record levels, US drug approval numbers continue to set the pace globally.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Pressures on FDA will affect industry’s success in bringing new therapies to market.

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.

Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.

According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.

The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.

The app, CURE ID, is designed to allow the clinical community to report their experiences treating infectious diseases with novel uses of existing FDA-approved drugs.

FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.

The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.