Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Gottlieb's FDA

November 15, 2018 | Daily News

FDA drug center director Janet Woodcock said rising drug prices are changing the nature of debate surrounding the agency’s drug development requirements.

November 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb tried to assure a National Academies of Sciences, Engineering and Medicine (NASEM) committee that while the agency plans to develop and publish prescribing guidelines for acute pain, the agency does not intend to regulate the practice of medicine.

November 15, 2018 | Daily News

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

November 13, 2018 | Daily News

A leading public health advocate official is hopeful the incoming Democratic-led House will investigate FDA’s controversial approval of the sufentanil drug DSUVIA.

November 13, 2018 | Daily News

A health care lawyer said a bill recently introduced in the Senate that would give FDA authority to require generic drug manufacturers update their labels would be greatly improved if it included liability protection for generics.

November 12, 2018 | Daily News

In its latest bid to tackle the problem of drug shortages, FDA plans to collect and analyze the information it gathers from inspections of sterile injectable drug manufacturing facilities in hopes of spotting and resolving problems before shortages occur.

November 12, 2018 | Daily News

Health care watchers predict that if OTC monograph reform legislation does not make it to the president before the end of the year, renewed debates around the legislation’s industry incentives could stall the bill in 2019, especially if New Jersey Democrat Frank Pallone, who was critical of the incentives included in the House-passed bill, becomes the new Energy & Commerce chair.

November 09, 2018 | Daily News

FDA is taking steps to both improve its existing Expanded Access Program and simultaneously implement the recently enacted Right to Try law, which agency commissioner Scott Gottlieb stressed Thursday (Nov. 8) are separate distinct pathways by which certain patients can get experimental drugs.

November 08, 2018 | Daily News

As more states -- including three during the recent midterm elections -- legalize marijuana, either for recreational or medical purposes, health care experts point out that the industry still lacks manufacturing controls and regulations, which they say can pose problems for patients who use marijuana medicinally, as well as for a growing industry that needs guidance and consistency.

November 08, 2018 | Daily News

FDA issued draft guidance Tuesday (Nov. 6) that it hopes will help encourage drug and biological product sponsors to more often pool together clinical studies so they and the agency can use the information to better evaluate product safety.

November 08, 2018 | Daily News

FDA and the HHS Office of Inspector General are butting heads over whether the agency is equipped to address postmarket cybersecurity risks to medical devices.

November 08, 2018 | Daily News

Drug industry lawyers are calling for FDA to give more specific feedback during new product reviews to drug applicants, saying the agency’s current process leaves out crucial details and makes the process more frustrating and contentious than necessary.

November 06, 2018 | Daily News

As public support for legalization of marijuana increases, more states -- including four in the upcoming midterm elections -- are legalizing or considering legalizing marijuana, either for recreational or medical purposes.

November 06, 2018 | Daily News

FDA on Tuesday (Nov. 6) released a new app that agency chief Scott Gottlieb hopes will enable developers to collect real-world data from patients on new medical products.

November 05, 2018 | Daily News

FDA Commissioner Scott Gottlieb said his agency aims to provide more transparency on its mandatory recall authority for unsafe foods through a final guidance released Monday (Nov. 5). FDA will issue a mandatory recall if a food causes serious health consequences to humans or animals.

November 05, 2018 | Daily News

Responding to a comprehensive FDA report on a multistate E. coli outbreak that killed five people and hospitalized dozens this spring, a vocal consumer advocacy group urged FDA to rapidly implement the remaining steps of the Food Safety Modernization Act (FSMA), a seven-year-old law that aims to standardize mandatory food safety protocols and recordkeeping requirements for farms across the country.

November 05, 2018 | Daily News

The dietary supplements lobby has its hopes on Sen. Martin Heinrich (D-NM), who is slated by polls to defend his seat and keep his role as supporter of the supplement industry, which will say goodbye to its longtime champion in the Senate, Sen. Orrin Hatch (R-UT) in January.

November 02, 2018 | Daily News

Despite opposition from public health advocacy groups and the chair of one of its own advisory committees, FDA on Friday (Nov. 2) approved a new sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl, while promising to revisit how it reviews new opioids moving forward.

November 02, 2018 | Daily News

FDA’s psychopharmacologic drugs and drug safety advisory committees, in a joint meeting on Thursday (Nov. 1). voted against approval of a proposed new opioid combination drug indicated to treat major depressive disorder.

November 02, 2018 | Daily News

A new relationship between FDA and the Department of Defense (DOD) went official Friday (Nov. 2) with the announcement of a memorandum of agreement (MOU) that will formalize a framework agreed upon in January, under which FDA will work with DOD to accelerate access to medical products for the military.

Pages