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Though there is no regulation requiring they do so, companies that receive an FDA Form 483 should always provide a response in writing that is well-organized, comprehensive and includes adequate corrective actions to addresses deficiencies, says Rebecca Asente, an FDA compliance officer with the Office of Regulatory Affairs. Read More
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the FDA’s interest in prohibiting use of a product for an unapproved indication. Read More
In the latest FDA blow to Biocon Biologics, a July inspection of its insulin production facility in Johor, Malaysia, has been classified by the agency as “Official Action Indicated” (OAI), the most serious inspection classification and one step short of a warning letter or other enforcement action. Read More
Eli Lilly has filed lawsuits against 11 online pharmacies that are importing, selling and distributing products purported to contain the active ingredient Lilly’s blockbuster glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro (tirzepatide), a type 2 diabetes drug that’s expected to be approved soon for weight loss. Read More
In this edition of Quick Notes, we cover a pharmaceutical ingredient cartel, fake Ozempic pens and new transparency rules for the European Medicines Agency clinical trial information system. Read More
After an FDA advisory committee voted overwhelmingly against its ALS drug NurOwn, BrainStorm Cell Therapeutics announced that it is withdrawing the BLA for the drug so that it can conduct an additional phase 3 trial. Read More
The FDA has issued a new final guidance intended to facilitate the development and assessment of regenerative medicine therapy (RMT) products CBER regulates through identifying and recognizing voluntary consensus standards (VCS). Read More
In a court filing earlier this week, Department of Justice (DOJ) lawyers assailed lawsuits from Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) that allege the drug price negotiation provisions in the Inflation Reduction Act (IRA) are unconstitutional. Read More