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Intas Pharmaceuticals was hit with a 36-page, 11-observation Form 483 following an inspection of its facility in Ahmedabad, India, that reads like a comedy of errors. Read More
Rep. Frank Pallone, Jr. (D-N.J.) is pressing the FDA and NIH on their efforts to ensure ClinicalTrials.gov reporting requirements are followed, referencing recent findings in a letter to the agency chiefs that show significant sponsor compliance issues. Read More
Now is the time to overhaul drug development’s evidence generation system, wrote FDA Commissioner Robert Califf in the journal Clinical Trials. Read More
In a clear sign that the FDA is raising the bar for accelerated approvals, the agency has declined to grant Accelerated Approval for donanemab — Eli Lilly’s entry into the antiamyloid antibody race — saying there isn’t enough long-term data to support such a move. Read More
“The company has already instituted additional quality controls and expects to be able to consistently reduce NTTP levels to meet the long-term acceptable daily intake level this year,” Merck said. Read More
The FDA’s collaboration with the U.S. Patent Trade Office (USPTO) to bring down barriers that delay generics is off to a good start, according to FDA Commissioner Robert Califf, who points to drug companies’ “gaming tactics” as a major problem. Read More
The analytics firm Clarivate has named 15 drugs that are either likely to achieve blockbuster status or to be game-changers benefiting millions of patients in its report Drugs to Watch 2023. Read More
Undisclosed tadalafil and sildenafil in a “male enhancement” supplement and lorcaserin — a controlled substance that has been withdrawn from the U.S. market — hidden in a weight-loss supplement, have earned Adam’s Secret USA an FDA warning letter. Read More
The FDA encourages developers of drugs and biological treatments for monkey pox — or mpox — to request a preapplication meeting with the agency, according to a draft guidance released today. Read More