The FDA’s action is being taken to address a safety issue associated with the need to reformulate drug products that contain carbomers manufactured with benzene. The goal is to expedite and provide a clear and less burdensome path than might otherwise be required under the applicable Scale Up and Post Approval Changes (SUPAC) guidances for […]
On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]
According to an updated post on the Center for Biologics Evaluation and Research (CBER) webpage, there were twelve Biologics License Applications (BLAs) approved for products that had orphan drug (OD) status. Just to cite a few: Two were for treatment of sickle cell disease (SCD). One was for enzyme replacement therapy (ERT) in adult and […]
Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here). This Guidance covers the following four topics: Providing quantitative efficacy or risk information for the control group, when applicable; Presenting probability information in terms of absolute frequencies, percentages, and relative […]
Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language. Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]
The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem. The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here). This is a deep dive […]
Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (here). If you can get that out of your mouth without taking a breath, I think you must be a free diver. The issue of disseminating information […]
While most sponsors make direct payments for their user fees, if you are one of those that like to send the money via check or other non-electronic method, better make sure you take note of the new address for delivery of such payments. “The Food and Drug Administration (FDA) is providing notice that the courier […]
On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry. Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon. Dr. Downey opened […]
Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously. There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]
