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A Pennsylvania district court refused to certify a group of corporate and institutional drug purchasers as plaintiffs in a class-action antitrust suit against several drugmakers — saying the approximately two-dozen organizations in the class was relatively small and did not meet legal class-action requirements. Read More
The state of Maryland defended its law against generic drug price gouging in court, moving to dismiss a complaint brought by the industry’s trade group, the Association for Accessible Medicines. Read More
AbbVie filed a federal lawsuit in Delaware claiming Boehringer Ingelheim is illegally infringing on patents in its development of a Humira biosimilar. Read More
In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any eligible products and Orange Book changes involving their products by the end of August. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More
The Drug Enforcement Administration is proposing to lower its annual manufacturing limits on certain controlled substances for 2018 — which would cut back production of several classes of opioid painkillers and other scheduled pharmaceuticals, some between 10 and 25 percent. Read More
The FDA outlined plans coordinating CDER and the Office of Regulatory Affairs in inspecting manufacturing facilities seeking approval for new pharmaceuticals. Read More
Tasked with thinking beyond the agency’s current policy proposals, the FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner Scott Gottlieb. Read More
President Trump signed a package of legislation reauthorizing the FDA’s user fee agreements for the next five fiscal years — the culmination of over two years of work and negotiations between the federal government and private industry. Read More
Manufacturers must investigate and report to the FDA any deviation from regulations related to the core requirements of current good tissue practice within 45 days of discovery. Read More