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Pharmaceutical Industry › Disclosure Requirements › Transparency

Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

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The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

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?

Ropes & Gray LLP on

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

Akin Gump Strauss Hauer & Feld LLP on

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

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

Gardner Law on

The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

Morgan Lewis

DC Circuit Court: CMS Rule on Drug Pricing Disclosure Exceeds Statutory Authority

Morgan Lewis on

In an informative decision for challenging rules that portend government overreach, the US Court of Appeals for the District of Columbia Circuit upholds the invalidation of the Centers for Medicare and Medicare Services’ drug...more

Mintz - Health Care Viewpoints

Federal Appeals Court Affirms Lower Court Ruling: Drug Pricing Transparency Rule Exceeds HHS’s Regulatory Authority

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A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case,...more

Faegre Drinker Biddle & Reath LLP

Will Prescription Drug Price Disclosures Have an Impact?

Faegre Drinker Biddle & Reath LLP on

Colorado Passes New Law - The Colorado General Assembly recently passed new statute C.R.S. 12-42.5-308, which would require pharmaceutical manufacturer marketing employees or agents to present, at the time of marketing a...more

Mintz - Health Care Viewpoints

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

Mintz - Health Care Viewpoints on

Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...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

Mintz - Health Care Viewpoints

California Advances PBM Licensing and “Transparency” Law

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Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more

Mintz - Health Care Viewpoints

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

Mintz - Health Care Viewpoints on

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

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