The Food and Drug Administration (FDA) issued the final rule for title 21 of Code of Federal Regulations part 212 regarding the regulations on current good manufacturing practice for PET drugs. The regulations are intended to ensure that PET drugs meet the safety and quality assurance requirements of the Federal Food, Drug, and Cosmetic Act. The new regulation became effective December 12, 2011...

http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection (8/15/13 update). “The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be upda...

A medical researcher who took a political appointment with the Trump administration while working on major international meta-analysis of potential covid-19 treatments leaked preprint version research to senior government colleagues last year, documents released in congressional investigation show.1 Paul Alexander, former assistant professor at McMaster University Canada specialises health met...

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Defense Alliance for Advanced Medical Terminology (DAAMT). The purpose of the MOU is to enable government agencies to exchange information and jointly pursue research endeavors related to medical device safety and effectiveness.

The Food and Drug Administration (FDA) has determined the regulatory review period for Therma Choice5 Uterine Ballon Therapy System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims tha...

N Engl J Med 2003;349:474-85. Copyright © 2003 Massachusetts Medical Society. n the past five years, two drugs have been withdrawn from the market by the Food and Drug Administration (FDA) for causing severe liver injury, a potential danger that had not been fully recognized in the course of the preapproval clinical trials. Reports of adverse drug reactions of any type engender fear and skeptic...

A ntibiotic resistance has become a worldwide problem for treating infections caused by numerous organisms. Safe, effective antimicrobials that are not easily subject to resistance are desperately needed. The Food and Drug Administration (FDA) states on its website: “Disease-causing microbes that have become resistant to drug therapy are an increasing public health problem. Tuberculosis, gonorr...

The reviewer is a long-time critic of hypnotics who has recently proposed U.S. Food and Drug Administration action to mandate additional Phase IV safety trials or else to restrict hypnotic indications. See Sleep Medicine, 2016, http://dx.doi.org/10.1016/j.sleep.2015.12.011 , the FDA documents at https://www.regulations.gov/#!docketDetail;D=FDA-2015-P-3959 and www.DarkSideOfSleepingPills.com . R...

The US Food and Drug Administration (FDA) recently issued a draft Guidance for Industry for Rare Diseases: Common Issues in Drug Development (referred to as "Rare Diseases Guidance"). In our opinion, the FDA should consider: (a) explicitly acknowledging the standards are higher for rare diseases for the reasons presented in this article; and (b) illustrating innovative development pathways that...