Archive for April 2022

The FDA needs funding for technological advancements and updated infrastructure, buildings and facilities, Commissioner Robert Califf told a Senate subcommittee discussing the agency’s fiscal year 2023 budget requests. Source: Drug Industry Daily

The FDA is seeing “new lows in data integrity” relating to generic drug applications, an agency official said at the agency’s two-day Generic Drugs Forum 2022, April 26-27. Source: Drug Industry Daily

After pocketing positive phase 3 topline results, Novartis will ask regulators to approve its checkpoint inhibitor tislelizumab as first-line add-on therapy for patients with previously untreatable esophageal squamous-cell carcinoma (ESCC). Source: Drug Industry Daily

The FDA has issued warning letters to five drugmakers producing several products including topical anesthetics, skin-bleaching products and hand sanitizers. Source: Drug Industry Daily

Johnson & Johnson (J&J) subsidiary Janssen has become the second big pharma company to go after drug distributors to stop the sale of counterfeit versions of its HIV drugs. Source: Drug Industry Daily

The FDA has issued final guidance for industry on making postmarket safety submissions in electronic format to its Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER). Source: Drug Industry Daily

Sen. Elizabeth Warren (D-Mass.) has written to ask Health and Human Services Secretary Xavier Becerra to lower prescription drug prices using an obscure and controversial regulatory authority known as “march-in rights.” Source: Drug Industry Daily

In a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP) yesterday, ranking member Sen. Richard Burr (R-N.C.) characterized the funding in the FDA’s reauthorization agreements as “double the money for mediocre performance.” Source: Drug Industry Daily

Sponsors are still not where they should be on meeting postmarket trial requirements and commitments, the FDA’s latest analysis shows: 24 percent of annual status reports for required or agreed upon postmarket trials were either late or unfiled in fiscal 2020. Source: Drug Industry Daily

Shionogi’s investigative COVID-19 therapy is showing some promise in early laboratory studies, rapidly clearing viral levels and decreasing the period of active shedding, the company reported at the European Congress of Clinical Microbiology and Infectious Diseases. Source: Drug Industry Daily