We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
The FDA hit an Ohio outsourcing facility with an extensive Form 483, listing failures to adhere to GMP and overall sterility, cleaning and quality control issues—with several problems repeated from an inspection a year before. Read More
Celltrion has filed two petitions against a Genentech patent with the PTO, requesting an inter partes review of a method for making antibodies related to Herceptin. Read More
Amgen is suing Coherus Biosciences over its processes for manufacturing a biosimilar of Neulasta, saying it infringes patented methods for purifying proteins. Read More
Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit. Read More