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Prescription Drugs › Regulatory Oversight › Disclosure Requirements

DLA Piper

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

DLA Piper on

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

Hogan Lovells

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

Hogan Lovells on

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

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

McCarter & English, LLP on

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Gardner Law

FDA Faces Pressure to Enhance Oversight of Online Prescription Drug Promotions

Gardner Law on

The U.S. Food and Drug Administration (FDA) is facing pressure from Congress and the medical community to enhance its oversight of online prescription drug advertising. The pressure comes amidst growing concerns about social...more

Sheppard Mullin Richter & Hampton LLP

The New California Regulatory Scheme for Pharmacy Benefit Managers

Sheppard Mullin Richter & Hampton LLP on

California recently passed Assembly Bill 315 to create greater regulatory oversight of pharmacy benefit managers (“PBMs”). The bill requires PBMs to provide more transparency regarding their operations. PBMs will have to...more

Akerman LLP - Health Law Rx

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

Akerman LLP - Health Law Rx on

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

Hogan Lovells on

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

Robinson+Cole Data Privacy + Security Insider

New HHS Secretary Delays Effective Date of Part 2 Final Rule

Robinson+Cole Data Privacy + Security Insider on

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

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