With the recent publication of numerous, previously unpublished complete response letters, coupled with its plans to increase these disclosures going forward, FDA has taken a significant step forward in its previously stated commitments to transparency. FDA has framed this initiative
As Prescribed
As Prescribed, published by Morgan Lewis, focuses on regulatory and legal developments in the pharmaceutical and medical device sectors. The blog covers topics such as updates to European Union pharmaceutical legislation, FDA policies on digital health and biosimilars, and regulatory frameworks for rare disease therapies in the UK. It addresses changes in compliance requirements, approval processes, and enforcement discretion by regulatory agencies. The content also includes discussions on databases for medical devices and evolving standards for clinical trials and marketing authorizations, reflecting ongoing shifts in healthcare law and policy.
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Marketing Medical Devices: Navigating Increased FDA Scrutiny
With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC) prescription drug advertising, and the subsequent issuance of…
FDA Announces Crackdown on DTC Advertising: What It Means for Pharma and What Comes Next
The White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly increase its enforcement of…
Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?
On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental biologics license application for the…