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FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act...


Homeopathic drug product makers warned to follow FDA premarket and GMP rules

Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing...


Modernization of U.S. cosmetics regulation will be phased in over time

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022...


FDA pushes OTC switch for naloxone, continuing trend toward making more drugs available without a prescription

The U.S. Food and Drug Administration (FDA) recently issued the Federal Register notice “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription...


FDA invites comments on Expanded Access to Investigational Drugs guidance

The U.S. Food and Drug Administration (FDA) recently issued a revised version of the draft guidance “Expanded Access to Investigational Drugs for Treatment Use – Questions and...


FDA explains how to use secondary endpoints in clinical trials to show efficacy

The U.S. Food and Drug Administration (FDA) recently finalized the guidance “Multiple Endpoints in Clinical Trials,” which advises drug sponsors on how to separate analyses of...


Seeking harmony: FDA to align its human subject research regulations with Common Rule

Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal...


“Advancing Real-World Evidence Program” offers drug sponsors early FDA meeting opportunity

FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in...


FDA offers new guidance on charging for investigational drugs

On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which...

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