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Life Sciences › Food and Drug Administration (FDA) › Drug Approvals

Robins Kaplan LLP

ANDA Approvals

Robins Kaplan LLP on

New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Brownstein Hyatt Farber Schreck

FDA’s Drug Review Gold Standard

Brownstein Hyatt Farber Schreck on

Robert F. Kennedy Jr., President-elect Trump’s nominee for secretary of health and human services, has said one of his mandates from the president-elect is to return agencies to the gold standard of scientific review. This...more

Wilson Sonsini Goodrich & Rosati

FDA Issues New Guidance on Charging for Investigational Drugs

Wilson Sonsini Goodrich & Rosati on

Conducting a clinical trial is a notoriously expensive endeavor that is necessary not only for ultimate drug approval, but even to progress to the next phase of drug investigation and development. An unfortunate consequence...more

Morgan Lewis - As Prescribed

A Closer Look at Accelerated Approval and Confirmatory Trials

Morgan Lewis - As Prescribed on

The accelerated approval pathway (i.e., the pathway that permits FDA to rely on surrogate or intermediate endpoints for the approval of a drug for serious conditions with unmet medical needs) has proven to be an important...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Smart & Biggar

First year of Project Orbis leads to 38 approvals of cancer therapies, including 8 by Health Canada

Smart & Biggar on

Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more

Hogan Lovells

What comes out, must go back in: Court sides with FDA on "same surgical procedure" and "homologous use" definitions governing...

Hogan Lovells on

FDA authority to crack down on illegally marketed stem cell treatments confirmed - On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug...more

Foley & Lardner LLP

Trump's Proposed 2018 Budget Will Double FDA User Fees

Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

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