food and drug administration
New FDA Pathway to Accelerate Development of Cell Therapies
New FDA Pathway to Accelerate Development of Cell Therapies
Jef Akst | May 22, 2017
Four products have already qualified for the regenerative medicine advanced therapy (RMAT) designation that provides extra interactions with the agency, and sooner.
Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
John D. Loike and Jennifer Miller | Feb 1, 2017
What can be done to lower development costs and drug prices?
New FDA Center Aims to Expedite Cancer Treatment Reviews
New FDA Center Aims to Expedite Cancer Treatment Reviews
Alison F. Takemura | Jun 30, 2016
The Oncology Center of Excellence, a product of the White House’s Cancer Moonshot initiative, will bring together oncologists across the US Food and Drug Administration.
FDA Head Confirmed
FDA Head Confirmed
Tracy Vence | Feb 24, 2016
The US Senate approves the Obama administration’s nominee, Robert Califf, as the next commissioner of the Food and Drug Administration.
FDA to Test for Glyphosate in Food
FDA to Test for Glyphosate in Food
Tracy Vence | Feb 22, 2016
The US Food and Drug Administration will begin testing certain foods for residues of the active ingredient in the herbicide Roundup.
Pharma Firms Comply with New Antibiotics Rules
Pharma Firms Comply with New Antibiotics Rules
Rina Shaikh-Lesko | Mar 31, 2014
Most drug manufacturers agree to follow the Food and Drug Administration’s new labeling guidelines for antibiotics used in farm animals.
FDA Considers Easing Controls on Diabetes Drug
FDA Considers Easing Controls on Diabetes Drug
Dan Cossins | Jun 11, 2013
A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
 
The Elixir Tragedy, 1937
The Elixir Tragedy, 1937
Jef Akst | Jun 1, 2013
A mass poisoning of 105 patients treated with an untested medication spurred Congress to empower the US Food and Drug Administration to monitor drug safety.
How Safe Is Your Medicine Cabinet?
How Safe Is Your Medicine Cabinet?
Megan Scudellari | May 1, 2013
After numerous high-profile safety scares, clinicians and regulators push to fix critical weaknesses in the FDA’s monitoring system for approved drugs.
Hurry Up, FDA
Hurry Up, FDA
Jef Akst | Dec 6, 2012
The US Food and Drug Administration is taking steps to get new devices on the market sooner—and antibiotics may be next.