Dennis Gucciardo on Food and Drug Administration (FDA)

FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more

7/20/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Inspections , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Supply Chain

Staying Within the Legal Lane: Providing Products and Services for COVID-19

Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more

7/9/2020 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratory Testing , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Immunity , Product Defects , Public Readiness and Emergency Preparedness Act (PREP Act) , Risk Mitigation , Suppliers , Supply Chain , Telehealth

Inspections Remain on Hold; FDA Collaborates with CDC to Develop a Process to Resume Program

Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more

5/29/2020 / FDA Approval , Food and Drug Administration (FDA) , Inspections , Life Sciences , Pharmaceutical Industry

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

4/8/2020 / Adverse Events , Biologics , Dietary Supplements , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs

COVID-19: Transforming Your Manufacturing Operations to Supply Critical-Need Medical Devices

The White House is reportedly in discussions with US auto companies to aid in the coronavirus (COVID-19) relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make...more

3/22/2020 / Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , New Guidance

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

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

3/20/2020 / Biotechnology , CGMP , Coronavirus/COVID-19 , Crisis Management , Food and Drug Administration (FDA) , Inspections , Life Sciences , Medical Devices , Pharmaceutical Industry

Recent FDA Medical Device Developments in Response to COVID-19

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

FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document...more

3/12/2020 / 510(k) RTA , Automation Systems , CDRH , Electronic Filing , FDA Approval , Federal Pilot Programs , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

Dennis Gucciardo

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