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The company also relied on suppliers’ certificates of analysis for incoming components “without establishing the reliability of [the] suppliers’ test results,” the agency said. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More
The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More
The Federal Trade Commission (FTC) has filed an amicus brief urging the U.S. District Court for the District of Delaware not to dismiss the suit brought by Sage Chemical and its marketing partner TruPharma against Supernus Pharmaceuticals over alleged blocking of generic competition. Read More
The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Read More
Members of an FDA advisory committee agreed in a 5-3 vote yesterday that clinical data on Biogen’s tofersen — a first-in-class drug candidate for a rare type of amyotrophic lateral sclerosis (ALS) — didn’t support a full approval, but said it might pass muster for an Accelerated Approval. Read More
Dunagin Pharmaceuticals of Rogers, Ark., received an FDA warning letter for manufacturing drugs on the same equipment used to manufacture non-drug products and failing to test samples of product components for its pharmaceutical and nonpharmaceutical dental care products, among other lapses. Read More