Regulatory Affairs Syndicator

Progenics Pharmaceuticals’ PRO 140 has been designated a fast track product by the US Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus (HIV) infection.

A key Senate Republican pressed the U.S. Food and Drug Administration on Thursday for details on its role in the clinical trial of an experimental blood substitute being tested on trauma patients in 18 states, in some cases without their consent.

The Food and Drug Administration said Thursday a bolstered risk management program for Accutane will begin March 1. The program, called iPLEDGE, will apply to Rcche’s Accutane and its generic versions.

Montgomery County is suing the Food and Drug Administration, county officials announced Thursday, charging the agency unfairly denied its request to reimport low-cost prescription drugs from Canada.

WASHINGTON (Reuters) - A Food and Drug Administration position that federally approved prescription drug labels are not subject to state liability laws should be reversed, Democratic lawmakers said on Thursday.

The U.S. Food and Drug Administration clarified its definition of “whole grains” last week, several months after recommending that Americans incorporate more whole grains in their diets.

A Food and Drug Administration position that federally approved prescription drug labels are not subject to state liability laws should be reversed, Democratic lawmakers said on Thursday.

ROCKVILLE, Md., Feb. 23 (UPI) — The Food and Drug Administration said Thursday a bolstered risk management program for Accutane will begin March 1. The program, called iPLEDGE, will apply to Rcche’s Accutane and its generic versions.

The U.S. Food and Drug Administration clarified its definition of “whole grains” last week, several months after recommending that Americans incorporate more whole grains in their diets.

The U.S. Food and Drug Administration has issued a nationwide recall for some GENTLEASE powdered infant formula that may contain metal particles up to 2.7 millimeters in size.

County seeks right to obtain prescription medications from Canada Montgomery County filed a lawsuit today against the Food and Drug Administration, claiming the agency unfairly barred it from importing lower cost prescription drugs from Canada for its employees.

WASHINGTON - A registry program intended to prevent use of the acne drug Accutane by pregnant women will begin next week as planned following an earlier delay, federal regulators said Thursday. The iPledge system will start Wednesday, the Food and Drug Administration said.

WASHINGTON, Feb 23 (Reuters) - The U.S. Food and Drug Administration on Thursday said it will implement new restrictions on a widely used acne drug next Wednesday in an effort to curb birth defects, rejecting calls from some doctors to delay the program.

The Food and Drug Administration on Thursday said it will implement new restrictions on a widely used acne drug next Wednesday in an effort to curb birth defects, rejecting calls from some doctors to delay the program.

WASHINGTON, Feb 23 (Reuters) - The U.S. Food and Drug Administration on Thursday said it will implement new restrictions on a widely used acne drug next Wednesday in an effort to curb birth defects, rejecting calls from some doctors to delay the program.