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The COVID-19 pandemic has spurred the World Health Organization (WHO) to release new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics. Read More
Developing a good working relationship with your regulatory project manager (RPM) at the FDA is “the single most important thing you can do” to improve communication during a regulatory review, an agency official said at the FDA’s Regulatory Education for Industry Annual Conference. Read More
The FDA issued an advisory to drugmakers about the risk of bacterial contamination of non-sterile water-based drug products by Burkholderia cepacian (BCC). Read More
FDA investigators observed various quality deficiencies during inspections of drug manufacturing facilities in North Carolina, Kansas, Florida and California. Read More
The FDA sent a warning letter to Round Rock, Texas-based Davati Medical Supply instructing it to stop marketing an unapproved quadrivalent influenza vaccine. Read More
The FDA added some clarifications in a final guidance for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical gases, and combination products containing a drug constituent part. Read More
The FDA issued a warning letter to generic drugmaker Lupin for good manufacturing practice (GMP) violations observed during an inspection of its plant in Somerset, New Jersey. Read More
The FDA explained in a new Manual of Policies and Procedures (MAPP) how generic drug sponsors can get their applications approved even if the submission coincides with labeling changes to the reference drug. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new quality guideline for sponsors of drug-device combination products that will go into effect on Jan. 1. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More
An FDA inspection of Dr. Reddy’s active pharmaceutical ingredient (API) manufacturing plant in Middleburgh, New York earlier this year found lapses in good manufacturing practice (GMP). Read More
Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and Research in a memorandum about the plant’s operations. Read More