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CDER has opened the grant submission process for awarding $700,000 to independent organizations that propose holding meetings among a broad range of stakeholders to explore development and implementation of medical policy. Read More
Holes in the roof, potential mold on and around air vents, and an employee’s garment extensively touching filling apparatus are among the observations listed in the FDA’s Form 483 levied on India-based generic pharma Zydus Lifesciences. Read More
A federal judge has dismissed Eli Lilly’s case against a Florida-based online compounding pharmacy selling copycat Mounjaro (tirzepatide), ruling that only the U.S. government has enforcement authority of the Food, Drug, and Cosmetic Act (FD&C Act), Lilly cannot use state laws for private enforcement. Read More
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More
The number of ongoing and active U.S. drug shortages peaked at 323 during the fourth quarter of 2023 — and 48 new medicines have been added to the list so far this year — with last year’s figure marking the highest number since the University of Utah Drug Information Service started tracking this data in 2001. Read More
Members of Parliament adopted their proposals to revamp EU pharmaceutical legislation aimed at fostering innovation and enhancing the security of supply, accessibility and affordability of medicines. Read More
Biosimilar sales appear generally strong, despite market struggles for Hadlima, Samsung Bioepis’ biosimilar challenger for AbbVie’s Humira (adalimumab), and other Humira challengers, according to the company’s first quarter biosimilar market report. Read More
Cipla, the third largest pharmaceutical company in India, received a Form 483 after an FDA inspection March 28-April 4 reported failures in cleaning and maintenance to prevent contamination as well as failures to investigate out of specification product. Read More
The Department of Justice (DOJ) filed a complaint under the False Claims Act (FCA) against Regeneron Pharmaceuticals alleging that the company knowingly submitted average sales price (ASP) reports to CMS that resulted in inflated Medicare reimbursements to the company. Read More