Washington Drug Letter

The FDA is an important part of the solution to drug shortage crises, not a contributing factor to the issue, the agency wrote in response to a congressional report that blamed the agency’s regulatory actions for limiting the manufacturing capacity of much-needed products.

A federal judge has ordered the FDA to release additional pages of logs and documents concerning its surveillance of six current and former employees who reported device safety concerns to Congress and the U.S. Office of Special Counsel (OSC).

Drugmakers should describe how a product was designed in the quality target product profile (QTPP), which forms the basis for developing critical quality attributes (CQAs) and critical process parameters (CPPs) that ensure the product’s quality over time, the FDA says in a new Q&A guidance on development of quality systems.

Jazz Pharmaceuticals is calling on the FDA to rescind its acceptance of Roxane Laboratories’ ANDA for a generic version of Jazz’s narcolepsy drug Xyrem, saying the FDA prematurely accepted the application, violating federal law and harming Jazz and other potential ANDA sponsors.

The FDA issued an untitled letter to Validus Pharmaceuticals claiming the drugmaker’s website published misleading claims for its bipolar disorder drug Equetro.

A panel of FDA advisors called for swift approval of Genentech’s sBLA for Lucentis to treat diabetic macular edema (DME), saying the drug’s efficacy and safety profile far outweigh any statistical shortcomings.

A coalition of physicians, clinicians and health officials is asking the FDA to tighten up the language in opioid labels regarding indications and long-term use for non-cancer pain.

Bristol-Myers Squibb (BMS) has received an untitled letter for a sales aid for breast cancer drug Ixempra that allegedly made unsupported efficacy claims and broadened the drug’s indication.

The FDA is giving manufacturers of prescription anti-spasmodic, gastrointestinal and hypertension medications that were cited as unapproved drugs decades ago until Aug. 23 to inform the agency if they still want to appeal its decision on the need for an NDA.