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Norway and Sweden are advising men younger than age 30 and all people under 18 years old to avoid taking the Moderna COVID-19 vaccine because of its rare association with myocarditis and endocarditis. Read More
The companies are alleged to have paid each other — and other, unnamed companies — to manipulate price, supply and customer allocations between 2013-2015. Read More
One of the challengers of the law, the Healthcare Distribution Alliance, has members which include the three largest U.S. opioid distributors. Read More
Francis S. Collins, the scientist who led the Human Genome Project, has announced that he will retire from his 12-year post as leader of the National Institutes of Health (NIH) at the end of 2021. Appointed in 2009 by President Barack Obama, he is NIH’s longest-serving director. Read More
German drugmaker Boehringer Ingelheim (BI) is the latest biopharmaceutical company to get a letter from HHS saying the company’s unwillingness to participate in the controversial 340B drug discount program has been referred to the HHS Office of Inspector General. 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
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including sponsors of drug-device combination products — on quality-related control correspondence with the agency in a draft guidance released yesterday.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