Jessica Vaughn, Ph.D.

Jessica Vaughn, Ph.D.

Wiley Rein LLP

Contact
View Bio
RSS

Latest Posts › Food and Drug Administration (FDA)

Share:

Time’s Up! Cosmetic Facilities Must Comply With FDA’s New Registration Requirements by July 1

The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more

6/18/2024  /  Cosmetics , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health and Safety , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Personal Care Products , Product Labels

The End of an Era: FDA Announces Disposition Plans for COVID-19 Related Guidance Documents

The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more

3/17/2023  /  CDRH , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Personal Protective Equipment , Public Health Emergency

FDA Proposes New Exemptions From IND Regulations for Certain Drug Use Clinical Studies of Food, Dietary Supplements, and Cosmetic...

In what could be a game-changer to the dietary supplement and food industry, the U.S. Food and Drug Administration (FDA or Agency) is proposing to amend the investigational new drug (IND) regulations to exempt clinical...more

12/9/2022  /  Clinical Trials , Cosmetics , Food & Drug Regulations , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Life Sciences , Pharmaceutical Industry

Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more

11/8/2022  /  CDRH , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Premarket Approval Applications , Public Health Emergency

In Case You Missed It: Takeaways from Final Guidance for Submitting Pre-Launch Activities Importation (PLAIR) Requests to FDA for...

The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled “Pre-Launch Activities Importation Requests (PLAIR)” (Final Guidance). ...more

5/23/2022  /  Abbreviated New Drug Application (ANDA) , Center for Drug Evaluation and Research (CDER) , CGMP , Food and Drug Administration (FDA) , Life Sciences , Office of Regulatory Affairs (ORA) , Pharmaceutical Industry
5 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide