Add to ORKGFive leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX ® (varenicline) tablets, a smoking cessation aid approved under NDA 021-928. The petitioners are the Institute for Safe Medication Practices, a nonprofit organization devoted entirely to medication error prevention and safe medication use; Consumer Reports, which serves consumers through unbiased product testing and ratings, research, public education and advocacy; National Center for Health Research, a nonprofit think tank that scrutinizes scie...
to the Food and Drug Administration (FDA) on the notice of proposed rulemaking that would deem certa...
Administration’s (FDA) release of its Draft Guidance for Industry on Reference Product Exclusivity f...
The U.S. Food and Drug Administration (FDA) drug approval system has sought to strike a balance betw...
Re: Citizen Petition to reclassify E-cigarettes from “drug-device combination ” to “tobacco product”...
FDA to Create Drug Safety Board In February 2005, the Food and Drug Administration (FDA) announced t...
The current Food and Drug Administration (FDA) system of regulating drug safety has serious limitati...
In January 2018, Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA), stat...
A total of 45 new chemical entities had been approved in 1997 by the Food and Drug Administration (F...
It is rare in the current political climate for a regulatory scheme to receive broad support – inclu...
The Dietary Supplement Health and Education Act of 1994 (DSHEA) was established by the United States...
A letter report issued by the Government Accountability Office with an abstract that begins "The Foo...
Testimony issued by the Government Accountability Office with an abstract that begins "The Food and ...
The undersigned submits this petition under the generic bioequivalence guidelines of the Federal Foo...
Last week, two separate advisory committees of the Food and Drug Administration assembled in the sub...
The Food and Drug Administration (FDA) creates the climate for the development of new drugs and clin...
to the Food and Drug Administration (FDA) on the notice of proposed rulemaking that would deem certa...
Administration’s (FDA) release of its Draft Guidance for Industry on Reference Product Exclusivity f...
The U.S. Food and Drug Administration (FDA) drug approval system has sought to strike a balance betw...
Re: Citizen Petition to reclassify E-cigarettes from “drug-device combination ” to “tobacco product”...
FDA to Create Drug Safety Board In February 2005, the Food and Drug Administration (FDA) announced t...
The current Food and Drug Administration (FDA) system of regulating drug safety has serious limitati...
In January 2018, Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA), stat...
A total of 45 new chemical entities had been approved in 1997 by the Food and Drug Administration (F...
It is rare in the current political climate for a regulatory scheme to receive broad support – inclu...
The Dietary Supplement Health and Education Act of 1994 (DSHEA) was established by the United States...
A letter report issued by the Government Accountability Office with an abstract that begins "The Foo...
Testimony issued by the Government Accountability Office with an abstract that begins "The Food and ...
The undersigned submits this petition under the generic bioequivalence guidelines of the Federal Foo...
Last week, two separate advisory committees of the Food and Drug Administration assembled in the sub...
The Food and Drug Administration (FDA) creates the climate for the development of new drugs and clin...
to the Food and Drug Administration (FDA) on the notice of proposed rulemaking that would deem certa...
Administration’s (FDA) release of its Draft Guidance for Industry on Reference Product Exclusivity f...
The U.S. Food and Drug Administration (FDA) drug approval system has sought to strike a balance betw...