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Manufacturers Inspections

Venable LLP

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

BIS Updates October 2022 Semiconductor Export Control Rules

On October 17, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released two interim final rules to reinforce and expand controls on (a) advanced semiconductors and related computing items (the...more

Akin Gump Strauss Hauer & Feld LLP

Commerce Imposes Significant New Controls on Advanced Semiconductors

On October 17, 2023, the Commerce Department’s Bureau of Industry and Security (BIS) released three rules amending the Export Administration Regulations (EAR) that significantly build on the October 7, 2022 semiconductor...more

Katten Muchin Rosenman LLP

Freedom of Breach: EU Commission Finds Pierre Cardin and Ahlers Group in Violation of Antitrust Rules - Katten Kattwalk | Issue 26

French fashion house Pierre Cardin (Cardin) and one of its oldest licensees, Ahlers Group (Ahlers), agreed to restrict cross-border sales and sales to specific customers. This is a clear breach of EU antitrust law, said the...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

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The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Jackson Walker

Mid-Year FDA Update: What’s New for Dietary Supplements?

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The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more

Husch Blackwell LLP

MoCRA: Good Manufacturing Practices – Why Should You Care?

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each...more

King & Spalding

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

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On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

Morgan Lewis - As Prescribed

FDA Embraces Alternative Tools for Inspecting Facilities

On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...more

Cozen O'Connor

Turbine Rotors Worldwide May Be Victims of Forged Inspection Data

Cozen O'Connor on

Japan Steel Works (JSW) is one of the largest manufacturers of power generation equipment parts, including rotor shafts for turbines and retaining rings that fasten the coils of generators. The company supplies these...more

Gardner Law

Are you Ready for Inspection? Best Practices to “Survive” FDA Inspections

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Companies often come to Gardner Law when they feel anxious or unprepared for a visit from the Food and Drug Administration (FDA). Even experienced companies with strong quality systems sometimes need assistance to be fully...more

Alston & Bird

Food and Drug Amendments of 2022 (PDUFA VII)

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Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more

Morgan Lewis

After a Series of False Starts, FDA Resumes Domestic Inspections

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FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more

Faegre Drinker Biddle & Reath LLP

FDA Inspection Readiness During the Pandemic

Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections. Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more

Arnall Golden Gregory LLP

There’s No Reply At All: It’s Never a Good Idea To Ignore FDA During an Inspection (and, in Fact, It’s Illegal)

Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here)....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Alston & Bird

FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities

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Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s first guidance on remote interactive evaluations, a tool in response to the agency’s COVID-19 inspection postponements....more

Sheppard Mullin Richter & Hampton LLP

Breaking Down FDA’s New Remote Monitoring Strategy

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance,...more

Mintz - Health Care Viewpoints

FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?

In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more

Amundsen Davis LLC

OSHA’s New National Emphasis Program For COVID-19

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In response to an executive order signed by President Biden in January, OSHA recently launched a new national emphasis program focusing enforcement efforts on industries and employers most impacted by COVID-19. The...more

Arnall Golden Gregory LLP

Quality Agreements: An AGG Podcast Recap

A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - September 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Arnall Golden Gregory LLP

Houston, We Have A Problem: FDA Confirms That It Will Only Conduct Mission-Critical Inspections and Prioritized Domestic...

It has been almost seven months since the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency on January 31, 2020 due to the Coronavirus Disease 2019 (COVID-19).  The Food and...more

BakerHostetler

FDA Current Good Manufacturing Practice Inspections During the COVID-19 Pandemic

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In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more

Sheppard Mullin Richter & Hampton LLP

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract...more

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