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Manufacturers Pharmaceutical Industry Inspections

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

King & Spalding

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

King & Spalding on

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more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

Alston & Bird

Food and Drug Amendments of 2022 (PDUFA VII)

Alston & Bird on

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

Morgan Lewis on

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

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

Alston & Bird on

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

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

BakerHostetler on

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

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Arnall Golden Gregory LLP

FDA Releases an Internal Policy on Inspections (Selection of Drug Manufacturing Sites for Inspection)

The Food and Drug Administration (FDA) has released an internal policy related to risk-based scheduling and prioritization of surveillance inspections for drug manufacturing facilities. ...more

Arnall Golden Gregory LLP

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

Jones Day

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

Hogan Lovells

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

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In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

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