Komal Karnik Nigam

Komal Karnik Nigam

Hogan Lovells

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FDA’s creation of public database of 200 Complete Response letters raises questions

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

7/11/2025  /  Biotechnology , Disclosure Requirements , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements , Securities Litigation

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more

4/3/2025  /  Department of Health and Human Services (HHS) , Employees , Food and Drug Administration (FDA) , Government Agencies , Hiring & Firing , Layoffs , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements
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