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Disclosure Requirements › Food and Drug Administration (FDA) › 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complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications.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

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

Womble Bond Dickinson on

The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...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

McNees Wallace & Nurick LLC

FDA Extends Compliance for Restaurant Food Labeling and Seeks Additional Comments

McNees Wallace & Nurick LLC on

The Food and Drug Administration (FDA) has extended the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments....more

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