The undersigned, Daniel F. Kripke, M.D., submits this Citizen Petition under the Federal Food, Drug & Cosmetic Act, 21 C.F.R. §§ 10.30, to request that the Commissioner of Food and Drugs take the following administrative actions with respect to the so-called hypnotic drugs listed herein. For at least the following drugs: zolpidem, temazepam, szopiclone, zaleplon, triazolam, flurazepam, and quazepam, in all brands and forms prescribed to treat insomnia or patient reported sleep disorders, and any barbiturates including pentobarbital, amobarbital, and secobarbital still prescribed, either on- or off-label, to induce sleep, Petitioner requests the following actions
Background The appropriate management of chronic insomnia is crucial and prescribing of hypnotic dru...
The pharmaceutical industry is ground zero for many of the most challenging issues at the intersecti...
A t the February meeting, the ACG Board of Trustees approved a plan to move forward with the College...
The undersigned submits this petition under the generic bioequivalence guidelines of the Federal Foo...
Five leading nonprofit consumer, research and medical organizations identified below petition the Fo...
Insomnia is a prevalent disorder with deleterious effects such as decreased quality of life, and a p...
This petition is based on scientific evidence of increased risks of cancer, particularly breast, col...
Re: Citizen Petition to reclassify E-cigarettes from “drug-device combination ” to “tobacco product”...
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to t...
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to t...
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to t...
Every second patient has sleep disorder. Outcomes of decreased quality of sleep lead to serious medi...
on December 21, 2004 (“the Valeant Petition”) requesting that the Food and Drug Administration (“FDA...
To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to regulate the ma...
To amend the Federal Food, Drug, and Cosmetic Act to prescribe penalties for the possession of depre...
Background The appropriate management of chronic insomnia is crucial and prescribing of hypnotic dru...
The pharmaceutical industry is ground zero for many of the most challenging issues at the intersecti...
A t the February meeting, the ACG Board of Trustees approved a plan to move forward with the College...
The undersigned submits this petition under the generic bioequivalence guidelines of the Federal Foo...
Five leading nonprofit consumer, research and medical organizations identified below petition the Fo...
Insomnia is a prevalent disorder with deleterious effects such as decreased quality of life, and a p...
This petition is based on scientific evidence of increased risks of cancer, particularly breast, col...
Re: Citizen Petition to reclassify E-cigarettes from “drug-device combination ” to “tobacco product”...
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to t...
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to t...
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to t...
Every second patient has sleep disorder. Outcomes of decreased quality of sleep lead to serious medi...
on December 21, 2004 (“the Valeant Petition”) requesting that the Food and Drug Administration (“FDA...
To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to regulate the ma...
To amend the Federal Food, Drug, and Cosmetic Act to prescribe penalties for the possession of depre...
Background The appropriate management of chronic insomnia is crucial and prescribing of hypnotic dru...
The pharmaceutical industry is ground zero for many of the most challenging issues at the intersecti...
A t the February meeting, the ACG Board of Trustees approved a plan to move forward with the College...