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Prescription Drugs › Regulatory Requirements › Disclosure Requirements

DLA Piper

CRLs Made Public: What FDA’s New Policy Means For the Drug Industry

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The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more

Cozen O'Connor

FDA Transparency Push: CRLs Released

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On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

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On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

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This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Goodwin

FDA’s Push for “Radical Transparency”: Key Takeaways from the Agency’s Publication of Complete Response Letters

Goodwin on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

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The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Arnall Golden Gregory LLP

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

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When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

Gardner Law

Exercise Caution: Celebrity Endorsements of Medical Products

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Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

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In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

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We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

Hogan Lovells

U.S. Senate passes bill requiring prescription drug ads to include prices

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On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more

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