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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
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tadalafil and sildenafil in a “male enhancement” supplement and lorcaserin — a controlled substance that has been withdrawn from the U.S. market — hidden in a weight-loss supplement, have earned Adam’s Secret USA an FDA warning letter.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biological treatments for monkey pox — or mpox — to request a preapplication meeting with the agency, according to a draft guidance released today.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
Brand-name drugmakers will have to pay the UK government nearly $4.1 billion this year, a sharp increase from approximately $2.2 billion in 2022. Read More
In the ongoing battle of pro-life groups vs. the government on access to the so-called abortion pill, the FDA is pressing a Texas judge to reject a request by anti-abortion groups for a court order withdrawing federal approval for the drug. Read More