Generic Line

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scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs (OGD) says in new draft guidance on stability testing.

The FDA is projecting a sluggish start for its new biosimilars approval pathway.

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

Next 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.

The FDA appears poised to require clinical trial data from drugmakers seeking interchangeability designations for biosimilars, a move that could shrink the number of products aiming to achieve the standard, drugmakers and legal experts say.

India’s Group of Ministers on pharmaceutical pricing has until Thursday to decide on how far it will widen its price controls on generic drugs under its National List of Essential Medicines, and how to set those prices, an expert says.

India’s patent laws are coming under more intense scrutiny, with cases that could add new difficulties for foreign multinational companies.

BALTIMORE — CDER’s proposed new Office of Pharmaceutical Quality (OPQ) is needed to promote good manufacturing practice (GMP) standards in the preapproval setting — standardizing GMP assessments throughout a drug’s life cycle.

The FDA has issued dozens of draft and revised draft product-specific guidances that detail its recommendations for bioequivalence (BE) studies to support ANDAs.

A district court judge has largely sided with Jazz Pharmaceuticals’ definitions for patents on its narcolepsy drug Xyrem, and the outcome looks like a “clear win” in Jazz’s legal struggle to prevent generic competition from Roxane Laboratories, one analyst says.