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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
Panacea Biotec, a maker of generic and specialty pharmaceuticals as well as vaccines, got rapped with a nine-observation Form 483 for inadequate oversight of aseptic procedures and environmental conditions for sterile drugs and poor training of employees, among other lapses. 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The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and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
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. 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
The European Commission (EC) has unconditionally approved Pfizer’s $43 billion acquisition of Seagen, concluding that the transaction would not raise competition concerns in the EU, Iceland, Liechtenstein and Norway. 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
Over the past week, the FDA issued final guidances on testing for methanol in alcohol, premarket notification for magnetic resonance diagnostic devices, patient remote monitoring devices, benefit-risk assessments for new drug and biological products and voluntary consensus standards for regenerative medicine therapies. Draft guidance was issued on treatments for diabetic foot infections. Read More