Florida has submitted a plan to HHS for how the state will import lower-cost prescription drugs from Canada. Source: Drug Industry Daily

The FDA hit OTC drug manufacturer NeoBiotech Global of Auburn, Washington with a Form 483 for operating without a quality control unit and other serious violations. Source: Drug Industry Daily

The clock is ticking on the FDA’s enforcement discretion period for stem cells and other new therapies, and Congress raised concerns and questions with the agency about its plans going…

The FDA has approved new warnings for Xeljanz and Xeljanz XR (tofacitinib), including a boxed warning. The warning of an increased risk of blood clots and death applies to the…

The FDA hit Indoco Remedies with a warning letter for significant CGMP violations related to data integrity following an inspection of its production facility in Goa, India. Source: Drug Industry…

Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.)’s drug pricing package is headed to the Senate floor, following the Senate Finance Committee’s markup and 19-9 approval yesterday. Source: Drug Industry…

Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form…

Ongoing recalls of contaminated blood pressure drugs prompted the House Energy and Commerce Committee to call on Friday for a review of the FDA’s foreign drug inspection program. Source: Drug…

The FDA released final guidance for sponsors of drugs to treat or prevent serious flare-ups of skin disorders known collectively as epidermolysis bullosa (EB). Source: Drug Industry Daily

In a big week for Pfizer, the world’s second largest drugmaker earned the FDA’s approval for a biosimilar cancer treatment and signed up the agency’s former Commissioner Scott Gottlieb for…