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Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

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The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

ArentFox Schiff on

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

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On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

Arnall Golden Gregory LLP

I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC...

Arnall Golden Gregory LLP on

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more

Alston & Bird

FDA Issues Notice on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities and Requests...

Alston & Bird on

Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug substance-related impurities (NDSRIs) in...more

Goodwin

FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

Goodwin on

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

Quarles & Brady LLP on

The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

King & Spalding

FDA Alerts Pharmaceutical Manufacturers to Risk of Benzene in Certain Drugs

King & Spalding on

FDA Continues to Focus on Identifying and Controlling Trace Impurities in Drugs - On December 23, 2021, the U.S. Food and Drug Administration (“FDA”) alerted drug manufacturers that FDA was investigating the root cause of...more

Hogan Lovells

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

Hogan Lovells on

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

Alston & Bird

FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products

Alston & Bird on

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more

King & Spalding

New FDA Guidance on Control of Nitrosamine Impurities

King & Spalding on

FDA Releases Guidance on the Agency’s Understanding of Nitrosamine Impurities - On September 1, 2020, the U.S. Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry: Control of...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Announces That Domestic Inspections Will Resume

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On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...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

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

Searcy Denney Scarola Barnhart & Shipley on

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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