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…
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…
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,…
Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid…
Over the past week, the FDA published a request for comments on a meeting to discuss user fee financial transparency and efficiency. Source: Drug Industry Daily
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…
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…
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. Source: Drug Industry Daily
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…
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…