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Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
A newly introduced House bill would legalize the personal importation of prescription drugs nationally, following a Maine law enacted in 2013 that is currently facing a legal challenge brought by the pharmaceutical industry. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
The generics industry enters uncharted territory in 2014 as it adjusts to a landscape altered by monumental Supreme Court rulings in 2013 and the FDA’s proposed rule to authorize generic drugmakers, for the first time, to change product labeling in response to safety signals. Here’s an overview of the significant events that happened in 2013 and how they promise to shape the industry in 2014 and beyond. Read More
Pernix Therapeutics’ promotional webpage for its bronchitis drug Cedax has drawn an untitled letter from the FDA for making misleading claims and omitting risk information. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
Hot on the heels of Amgen’s state-level campaign to limit dispensation of biosimilars, the biotech is voicing strong opposition to plans by the FDA to allow biosimilars to share the same international non-proprietary name (INN) as the biologic they reference, calling for unique INNs. Read More