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Pharmaceutical Industry › Rulemaking Process › Food and Drug Administration (FDA)

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

Faegre Drinker Biddle & Reath LLP on

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

Polsinelli on

As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

Polsinelli on

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Hogan Lovells

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

Hogan Lovells on

Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

Mintz - Health Care Viewpoints

Trump Administration Releases Series of Executive Orders on Drug Pricing

Mintz - Health Care Viewpoints on

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more

Mintz - Health Care Viewpoints

OTC Monograph Reform: Key Takeaways and What Industry Can Expect

Mintz - Health Care Viewpoints on

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Hogan Lovells

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Hogan Lovells on

Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

Hogan Lovells

FDA Chief of Staff: OTC reform remains “top priority” for FDA

Hogan Lovells on

Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top...more

Hogan Lovells

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for...

Hogan Lovells on

On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including...more

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

Hogan Lovells on

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

Hogan Lovells

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

Hogan Lovells on

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

Mintz - Health Care Viewpoints

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

Mintz - Health Care Viewpoints on

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Foley & Lardner LLP

Can FDA Implement The BPCIA As The CAFC Suggested?

Foley & Lardner LLP on

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

King & Spalding

HHS Issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

King & Spalding on

On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission. The...more

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