Advertisement

FDA designation 'really big deal' for Athersys

By Crain's Cleveland Business  |  May 29, 2017

The U.S. Food & Drug Administration awarded Athersys' clinical program for stroke fast track designation, an expedited drug development and review program for new drugs or biologics to treat serious or life-threatening conditions.

Addiction experts question FDA's suggestion to cap opioid prescriptions

Addiction experts question FDA's suggestion to cap opioid prescriptions

By Virgil Dickson  |  May 25, 2017

FDA Commissioner Scott Gottlieb has suggested that limiting painkiller prescriptions could be a key tool to battle the opioid addiction crisis gripping the nation. Addiction experts say doctors should have the final say on when and how long the drugs are used.

Late news briefs for the week of May 13

By Modern Healthcare  |  May 13, 2017

The Senate's Committee on Health, Education, Labor & Pensions late last week voted 21-2 to approve a bipartisan bill that reauthorized the FDA's ability to collect fees from companies that make prescription brand drugs, medical devices, generic drugs and biosimilars.

FDA user-fee extension breezes through Senate committee

FDA user-fee extension breezes through Senate committee

By Alex Kacik  |  May 11, 2017

The act, which calls for more than $400 million in additional user fees to be collected from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, looks to expedite new drug approvals. The committee added amendments aimed at increasing competition.

Senate committee advances Trump pick to lead FDA and other late news

By Modern Healthcare  |  April 29, 2017

A Senate committee last week voted to send the nomination of Dr. Scott Gottlieb as head of the Food and Drug Administration​ to the full Senate. Members of the Senate Health, Education, Labor and Pensions Committee voted 14-9 to advance Gottlieb's nomination as FDA...

Advertisement
X

Subscribe and SAVE 50%

View our best offer
Subscribe to Print