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Gottlieb's FDA

November 29, 2018 | Daily News

A device industry lawyer alleges that FDA’s proposals to reform its 510(k) process violates the agency’s statutory authority, threatens to monkey around with the device market, and would increase the cost of device innovation and health care more generally.

November 29, 2018 | Daily News

A medical device expert and former FDA staffer says that the Medical Device Enforcement and Quality Report released by FDA on Nov. 21 appears intended to dispel criticism that the agency does not take sufficient enforcement action when appropriate while also appealing to Congress for help with funding for device-related postmarket activities.

November 29, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Nov. 28) took to Twitter to condemn a Chinese researcher who made headlines after announcing he had edited the genes of a set of twin girls born this month using the CRISPR-Cas 9 gene editing tool.

November 29, 2018 | Daily News

FDA once again issued a warning letter to an e-cigarette company for selling e-cigarette e-liquids with labeling or advertising that resembles kid-friendly food products and for illegally selling to a minor.

November 28, 2018 | Daily News

A day after releasing a plan to overhaul FDA’s clearance process for certain low- and moderate-risk medical devices, FDA Commissioner Scott Gottlieb defended his agency’s proposals amidst a wave of industry opposition to them and used cybsecurity concerns to make his point.

November 27, 2018 | Daily News

The International Consortium of Harmonisation agreed with FDA Commissioner Scott Gottlieb this month that its members should develop standard international approval requirements for generic drugs, which would facilitate simultaneous approvals in multiple markets.

November 27, 2018 | Daily News

Continuing drug shortage issues are a result of economic and policy failures that span many years, FDA Commissioner Scott Gottlieb told a crowd of researchers, health care providers, industry representatives and other experts during the agency’s Tuesday (Nov. 27) drug shortages public meeting, held in coordination with the Duke Margolis Center for Health Policy.

November 26, 2018 | Daily News

Device industry leaders were taken aback that FDA is considering publishing online the names of devices cleared using predicate devices that are 10 years old or older -- a move the agency announced Monday (Nov. 26) as part of a broader effort to modernize and tighten its medical device clearance process amid recent reports of safety issues.

November 26, 2018 | Daily News

FDA Commissioner Scott Gottlieb called low prices and CMS reimbursement for generic prescription drugs a “root cause” of drug shortages in a blog post he co-authored with the agency’s drug center chief, Janet Woodcock, last week.

November 21, 2018 | Daily News

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

November 21, 2018 | Daily News

One industry lawyer found that FDA has put out many more new rules for the food and medical device industries over the past six years than it has for other industries, such as drugs, biologics, cosmetics and animal feed.

November 20, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

November 20, 2018 | Daily News

FDA device center chief Jeff Shuren says that his agency, in order to consistently be the best in the world at identifying and responding to device safety signals, will need more resources to fuel its real-world evidence-gathering apparatus, the National Evaluation System for health Technology (NEST) and its coordinating center (NESTcc).

November 20, 2018 | Daily News

FDA is proposing to try out a minimally invasive dog drug study that the agency hopes will encourage industry to pursue similar studies, or ones that do not involve live dogs at all.

November 19, 2018 | Daily News

FDA Commissioner Scott Gottlieb said the agency hopes to boost its use of real-world evidence and other tools to analyze drug performance and support new indications, and he announced FDA will issue a framework to evaluate the use of RWE.

November 16, 2018 | Daily News

After months of deliberation and public meetings, FDA and the U.S. Department of Agriculture officially announced they will share the responsibility for regulating cell-based meats, where food resembling meat, poultry and seafood is produced using small amounts of cells from the animal that the food product is supposed to resemble.

November 15, 2018 | Daily News

In a highly anticipated move, FDA Commissioner Scott Gottlieb on Thursday (Nov. 15) announced a number of new tobacco-related initiatives the agency is undertaking, including revisiting the deeming rule compliance policy to restrict access to flavored electronic nicotine delivery systems (ENDS).

November 15, 2018 | Daily News

In a slate of tobacco-related policy proposals issued Thursday (Nov. 15), FDA Commissioner Scott Gottlieb said the agency will move forward with a proposed ban on menthol in combustible tobacco products, including cigars and cigarettes, as well as a ban on all flavored cigars.

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.

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