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The House of Representatives passed a bill in a bipartisan 368-56 vote on Oct. 19 that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process. Read More
Teva Pharmaceutical stopped drug manufacturing at its Irvine, Calif., facility following a recent FDA inspection that revealed lapses, including possible mold contamination caused by water leaks. Read More
The FDA issued warning letters to four drug manufacturing plants for failure to maintain good manufacturing practices — and to one firm for producing misbranded and unapproved drug products. Read More
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
The FDA’s vision of an enhanced drug distribution security program that would allow electronic tracing of every shipment is an impossibly complicated project that would take years to build, expose confidential company information and might even run afoul of federal law, said the Healthcare Distribution Alliance (HDA), the national organization that represents pharmaceutical distributors. Read More
FDA investigators observed inadequate investigations into bacterial contamination, documentation lapses and other quality deficiencies during inspections of six drug facilities. Read More
A Las Vegas, Nev.-based drug compounder, AnazaoHealth, has received a warning letter from the FDA for marketing unapproved new drugs and for how it handles adverse event reports. Read More
Despite contending that it didn’t need to submit investigational new drug (IND) applications for two COVID-19 trials of its novel glycan candidate, KB109, Kaleido Biosciences received a warning letter from the FDA explaining that it did in fact need to submit one. Read More
What type of notification the FDA will provide to a drug or biologics company that may not be complying with good manufacturing practices (GMP) depends on several factors, including the type of problem, the law and the agency’s internal regulatory procedures manual, agency officials said at the FDA/Parenteral Drug Association (PDA) joint regulatory conference. Read More
The FDA would like to know more about whether drug shortages are happening at the point of manufacture or downstream in the supply chain, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni said in remarks at the FDA/Parenteral Drug Association (PDA) joint regulatory conference. Read More