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Gottlieb's FDA

December 18, 2017 | Daily News

FDA Commissioner Scott Gottlieb announced Friday (Dec 15) the agency's intention to work with the U.S. Pharmacopeial Convention to develop standards for drugs that FDA has highlighted as off-patent, off-exclusivity and without generic competition.

December 18, 2017 | Daily News

FDA on Friday (Dec. 15) published guidance for sponsors of targeted therapies, including how to identify patients for clinical trials and how to present the benefits and risks of such therapies.

December 14, 2017 | Daily News

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

December 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices.

December 13, 2017 | Daily News

Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

December 13, 2017 | Daily News

The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition.

December 13, 2017 | Daily News

Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval.

December 07, 2017 | Daily News

FDA and CMS will increasingly work together on simultaneous diagnostic test reviews, a move that FDA Commissioner Scott Gottlieb told lawmakers Thursday (Dec. 7) could serve as “a powerful incentive” for more sponsors of diagnostic tests to voluntarily go through the FDA approval process.

December 07, 2017 | Daily News

FDA on Thursday (Dec. 7) took steps to fulfill the digital health provisions in the 21st Century Cures Act by issuing a suite of guidances that reveal which clinical decision support (CDS) tools won't be considered devices.

December 07, 2017 | Daily News

FDA last week approved the first medical device cleared for use with the Apple Watch following a 19-month review process largely due to the complexity and potential risk of the product's software, which can interpret diagnostic tests without any physician involvement.

December 05, 2017 | Daily News

FDA published final guidance Monday (Dec. 4) aimed at helping CMS determine which investigational devices to cover by streamlining the categorization of investigational device exemption (IDE) products -- completing a process launched in 2015 through a Memorandum of Understanding (MOU) between FDA's device center and CMS' Coverage and Analysis group (CAG).

December 05, 2017 | Daily News

A recently released draft guidance outlining the potential expedited pathways available to gene therapy sponsors assuaged concerns that therapies promising solely durable, rather than permanent, changes in a patient may not be eligible for the 21st Century Cures-created Regenerative Medicine Advanced Therapy (RMAT) designation, according to a new blog from attorneys at Hogan Lovells.

December 05, 2017 | Daily News

FDA's biologics center will encourage flexible clinical trial designs for regenerative medicine by considering trials that incorporate adaptive designs, enrichment strategies or novel endpoints.

December 05, 2017 | Daily News

One of FDA's newest regenerative medicine advanced therapies (RMAT) draft guidances provides the regenerative medicine industry with much-needed regulatory clarity and consistency, according to the head of lobby group Alliance for Regenerative Medicine (ARM), but some questions remain.

December 01, 2017 | Daily News

FDA on Thursday (Nov. 30) approved the first once-monthly buprenorphine injection -- a drug-device combination product -- to be used to treat moderate-to-severe opioid use disorder (OUD).

December 01, 2017 | Daily News

FDA will set out in guidance a policy of allowing complex generics and the brand product they are copying to have different labels so long as those changes reflect solely design differences, Commissioner Scott Gottleib said this week.

December 01, 2017 | Daily News

FDA is forming a Nicotine Steering Committee composed of agency leaders tasked with revamping FDA's policies surrounding nicotine replacement therapy (NRT) products, FDA Commissioner Scott Gottlieb, drug center chief Janet Woodcock and Center for Tobacco Products Director Mitch Zeller wrote in a Wednesday (Nov. 29) FDA Voice blog.

December 01, 2017 | Daily News

FDA has fulfilled a promise it first made in 2016 to list patent submissions dates in the Orange Book, making it easier for generic companies to discern whether the patent will trigger certain required Hatch-Waxman steps.

November 30, 2017 | Daily News

FDA is developing a policy by which the agency can approve subsequent indications of cancer drugs with less rigorous follow-up trials, FDA Commissioner Scott Gottlieb announced Thursday (Nov. 30).

November 30, 2017 | Daily News

For the second time, CMS agreed to cover a companion diagnostic on the day FDA approved it.

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