Washington Drug Letter

Generic-drug makers filing ANDAs and drug master files should provide six months of stability testing data, including accelerated and long-term conditions, and data from three pilot scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs (OGD) says in new draft guidance on stability testing.

Clinical trial sponsors could have an easier time qualifying trial sites and training investigators as a new Big Pharma initiative aims to standardize these procedures and support mutual recognition of qualification and training.

This month, the FDA will begin revealing its criteria for initial completeness tests for Type II active pharmaceutical ingredient (API) drug master files (DMF), an FDA official says.

Depomed is taking the FDA to court, claiming the agency violated federal laws and its own regulations when it denied the company’s orphan drug Gralise seven years of marketing exclusivity.

CINCINNATI ­— The FDA will issue guidance detailing what information drugmakers should share with contract manufacturing organizations (CMO) hired to work on their products, FDA officials say.

The Senate on Sept. 22 passed a fiscal 2013 spending extension that would keep the federal government and FDA funded at current levels through March 27.

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Sept. 20.

PhRMA has asked the Supreme Court to take up and overturn the 3rd Circuit Court’s decision that reverses patent settlements between generics and branded drug makers violate antitrust law.

The FDA will begin policing compliance with clinical trial submission requirements for ClinicalTrials.gov under a policy change at HHS.

Jazz Pharmaceuticals received an FDA warning letter for overstating the benefits and minimizing or omitting the risks of its schizophrenia drug FazaClo in a patient brochure.

An upcoming final FDA guidance on risk-based monitoring of clinical investigations will include more specifics for drugmakers on developing monitoring plans, as the industry has requested.

The FDA approved a second indication for Regeneron Pharmaceuticals’ Eylea to treat macular edema following central retinal vein occlusion (CRVO).