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Medical Devices › Pharmaceutical Industry › Inspections

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Sheppard Mullin Richter & Hampton LLP

FDA Expands Inspection Guidance to Apply to Device Manufacturers

Sheppard Mullin Richter & Hampton LLP on

On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” (the “Inspection Draft...more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FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance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On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

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

Faegre Drinker Biddle & Reath LLP

FDA Inspection Readiness During the Pandemic

Faegre Drinker Biddle & Reath LLP on

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

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

Morgan Lewis

FDA Suspends Routine Domestic Drug and Device Inspections Due to COVID-19

Morgan Lewis on

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Hogan Lovells

CFDA Continues to Expand Oversea Inspection

Hogan Lovells on

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good...more

Akin Gump Strauss Hauer & Feld LLP

FDA Implements a New “Concept of Operations” for Drug Inspections

Akin Gump Strauss Hauer & Feld LLP on

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Thomas Fox - Compliance Evangelist on

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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