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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including sponsors of drug-device combination products — on quality-related control correspondence with the agency in a draft guidance released yesterday.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
The guidance makes clear that all studies intending to use and submit such data need to have their protocols and statistical analysis plans submitted prior to initiation. Read More
This sort of action against CROs is something rarely seen from the FDA; the last occurrence was in April 2016 and involved another Indian CRO, Semler Research. Read More
Negotiations over settlements with Native American tribes are not covered by the ongoing settlement process involving state and local governmental entities. Read More