Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. Source: Drug Industry…

The FDA should allow developers of new and generic drugs more flexibility when they submit model-informed data, an advisory committee said. Source: Drug Industry Daily

The FDA has issued warning letters to two API manufacturers, citing branding and data integrity issues. Source: Drug Industry Daily

Mylan reached a settlement with Roche and Genentech that paves the way for the generic drugmaker to market a biosimilar version of the blockbuster drug Herceptin. Source: Drug Industry Daily

The USPTO's Patent Trial and Appeal Board validated four of Acorda’s patents on the multiple sclerosis drug Ampyra, but a federal court still has to determine whether five of the…

Amgen is calling on the U.S. Supreme Court to rule that biosimilar makers must wait six months after an FDA approval to market their therapy. Source: Drug Industry Daily

Two FDA advisory committees voted Tuesday that the benefits of a previously approved formulation of Opana ER no longer outweigh the risks of abuse. Source: Drug Industry Daily

Barcelona-based Infar received a Form 483 from the FDA for inadequate testing procedures, record-keeping, and sanitation. Source: Drug Industry Daily

The FDA slapped API manufacturer Dr. Reddy’s with a Form 483 over inadequate record-keeping and testing procedures. Source: Drug Industry Daily

The FDA is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the drug development process. Source: Drug Industry Daily