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The FDA’s guidance on developing topical corticosteroids provides ANDA applicants with recommendations on pilot and pivotal studies to assess bioequivalence of the drugs. Read More
In this edition of Quick Notes, we cover a Philips study confirming the safety of its cardiac diagnostic device, FTC action against deceptive marketing of a COVID-19 protection device, and updates to two FDA medical device event reporting databases. Read More
The FDA has smacked UCB Farchim for quality control lapses, among other deficiencies, following an inspection of its Bulle, Fribourg, Switzerland facility in June and July. Read More
In a new draft guidance, the FDA describes how it requests and conducts voluntary remote regulatory assessments (RRA), an evaluation the agency says it may conduct in lieu of or in support of an inspection. Read More
The FDA issued a complete response letter (CRL) for Sanofi and Regeneron’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU) requesting additional efficacy data, the companies announced on Friday. Read More
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The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and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