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It’s been a long time coming, but the FDA has finally published a pair of proposed rules designed to sync the agency’s institutional review board (IRB) and informed consent requirements with the Common Rule, the regulation used by most federal agencies to guide human subjects research. Read More
One day before the end of the fiscal year, the U.S. Senate passed a continuing resolution (CR) with FDA user fee authorization attached to it, moving closer to an 11th-hour funding of about half of the agency’s budget for the next five-years. Read More
Multiple comments on the FDA’s efforts to provide guidance on how sponsors can develop patient-focused clinical outcome assessments (COA) for regulatory decision-making called for more clarity on one of the four types of COA — patient reported outcomes (PRO) — and on using digital health technology (DHT) for COA data. Read More
The Center for Biologics Evaluation and Research’s (CBER) Office of Tissues and Advanced Therapies has been renamed the Office of Therapeutic Products (OTP). Read More
Following up on a provision of the CARES (Coronavirus Aid, Relief and Economic Security) Act on the regulation of over-the-counter (OTC) monograph drugs, the FDA has issued draft guidance on how submitters should send OTC monographs requests (OMOR) electronically prior to marketing a drug. Read More
Biogen has agreed to pay $900 million to resolve a federal whistleblower lawsuit charging that the company bribed doctors with kickbacks to prescribe its multiple sclerosis drugs, resulting in the submission of false claims to Medicare and Medicaid. Read More
The version of user fee legislation that’s slated to be attached to a continuing resolution (CR) later this week — just days before the end of the fiscal year — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Read More