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Gottlieb's FDA

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A recently released draft guidance outlining the potential expedited pathways available to gene therapy sponsors assuaged concerns that therapies promising solely durable, rather than permanent,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.

November 20, 2017 | Daily News

FDA is considering how real-world evidence (RWE) can be used to update product labels, and labeling may be the first area in which the agency develops a clear framework for the use of real-world evidence, agency Commissioner Scott Gottlieb told a group of stakeholders during Friends of Cancer Research's (FOCR's) annual meeting.

November 20, 2017 | Daily News

FDA Commissioner Scott Gottlieb plans to pilot a new hiring process starting in 2018 after an internal report unveiled by Gottlieb Wednesday (Nov. 15) revealed FDA's hiring process needs to be fundamentally redesigned.

November 17, 2017 | Daily News

Generic stakeholders are clashing with FDA over what most thought were completed Generic Drug User Fee Amendments (GDUFA II) negotiations, namely the steps sponsors must take to be eligible for priority review.

November 17, 2017 | Daily News

FDA issued long-awaited guidance answering industry questions about how to comply with its menu labeling rule, slated to go into effect May 7, 2018, but the industry noted it will exercise enforcement discretion for out-of-compliance companies to help them comply with the law.

November 17, 2017 | Daily News

FDA's recent alert on alleged health risks associated with the herbal product kratom is being challenged by the American Kratom Association, which is petitioning the agency under the Information Quality Act to set up a special advisory committee of independent experts to review the accuracy and integrity of the data underlying FDA's advisory, and to hold a public meeting on the product.

November 16, 2017 | Daily News

FDA has introduced a new risk-based framework, accompanied by two final guidances and two new draft guidances, for regulating regenerative medicines, the agency announced Thursday (Nov. 16).

November 06, 2017 | Daily News

FDA will work with the Department of Homeland Security and local authorities in Puerto Rico to help a subset of drug and device manufacturers to jump the line for getting back on the electrical grid, FDA Commissioner Scott Gottlieb announced Monday (Nov. 6) at an Association for Accessible Medicines conference.

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