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Prescription Drugs › Biologics › Drug Approvals

Hogan Lovells

FDA adds information on Commissioner’s National Priority Voucher program

Hogan Lovells on

This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National Priority Voucher” (CNPV) program, which will provide up to five vouchers in the program's...more

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Goodwin

Review of FDA’s 2021 Drug Approvals – Small Molecules Dominate

Goodwin on

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs and biological products in 2021 (not including the vaccines, cellular and gene therapy products, or other products approved in 2021 by the Center...more

Smart & Biggar

Update on biosimilars in Canada - October 2021

Smart & Biggar on

Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more

American Conference Institute (ACI)

[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

American Conference Institute (ACI) on

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more

Smart & Biggar

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

Smart & Biggar on

Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more

Smart & Biggar

Rx IP Update - January 2018

Smart & Biggar on

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

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