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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has proposed waiving certain requirements for biosimilars on “solid” evidence of quality comparability. Read More
Vanda Pharmaceuticals is once again suing HHS and the FDA, claiming that the agencies are using regulatory process to accomplish an “end run” around the timetable required by law in its efforts to obtain an approval or a hearing for a new indication for its drug Hetlioz (tasimelteon) as a treatment for insomnia. Read More
The guidance advises registrants that reports for calendar years 2020, 2021 and 2022 “are still required under the statute and should be submitted to the Agency as soon as possible.” Read More
The FDA’s Office of Clinical Pharmacology (OCP) conducted more than 5,600 reviews of investigational new drug (IND) submissions in 2023, helping determine correct dosing for 55 new drugs and biological products. Read More
The Fifth Circuit ruling fails to recognize a long history of federal court decisions in favor of FDA’s scientific autonomy, the brief notes. Read More
The FDA did not attend a House Energy and Commerce subcommittee hearing Tuesday focused on why the agency has stalled out on its pre-pandemic efforts to improve inspections of overseas manufacturers that supply drugs to the U.S. Read More
An analysis of 10 FDA approved drug-device combinations containing GLP-1 receptor agonists found that the patents for the device portion made no mention of active drug ingredients — a requirement of FDA Orange Book listing. Read More
The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s visibility into drug supply chains. Read More
By overriding the FDA’s scientific judgments and methodology, the Fifth Circuit second-guessed the FDA’s Congressional mandate to consider all scientific evidence in drug approval decisions, the American Bar Association (ABA) wrote in its recent amicus brief on the Supreme Court’s upcoming review of the abortion drug mifepristone. Read More
A bipartisan group of six senators have released proposed reforms to the beleaguered 340B drug discount program that they claim will ensure the program fulfills its original purpose of supporting covered entities helping underserved populations. Read More