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Enforcement Actions New Guidance Prescription Drugs

Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

Foley & Lardner LLP on

Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

Foley Hoag LLP

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

Foley Hoag LLP on

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

Proskauer - Employee Benefits & Executive...

The Greatest Gift of All…Tri-Agencies Issue Welcome Relief on Prescription Drug Reporting

Just three short days before the December 27th deadline for health plans and issuers to report prescription drug and health care spending information to the government, on December 23, 2022, the Departments of Labor,...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

ArentFox Schiff

Investigations Newsletter: DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases

ArentFox Schiff on

DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases - On October 8, 2019, Assistant Attorney General Brian Benczkowski announced new guidance for federal prosecutors evaluating whether a corporation is unable...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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