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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
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
The FDA is responding to frequently asked questions from generic drugmakers — including sponsors of drug-device combination products — on quality-related control correspondence with the agency in a draft guidance released yesterday. Read More
The extended certificates are necessary to prevent shortages of starting materials, reagents, intermediates or active substances, the regulators said. Read More
The European Medicines Agency (EMA) has decided that a COVID-19 booster dose from Pfizer/BioNTech or Moderna can be given to people with severely weakened immune systems 28 days following a second shot. Read More
A federal judge has shot down Pfizer’s proposal to help heart failure patients afford Vyndaqel (tafamidis meglumine) and Vyndamax (tamfadis), oral formulations of an expensive cardiac medication for treatment of transthyretin amyloid cardiomyopathy. Read More
Industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has filed a federal lawsuit arguing that a “misguided state mandate” in Arkansas relating to the 340B federal drug discount program is unconstitutional. Read More
A federal appeals court has ruled that the FDA incorrectly approved a rare disease drug from Jacobus Pharmaceuticals because Catalyst Pharmaceuticals already owned the rights to the drug. Read More