News & Analysis as of

Pharmaceutical Industry Disclosure Requirements Executive Orders

Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more

Goodwin

USPTO Doubles Down Calling Out Pharmaceutical Industry

Goodwin on

​​​​​​​The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties of disclosure and reasonable inquiry during examination of a patent application,...more

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