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Gottlieb's FDA

September 13, 2018 | Daily News

FDA issued 54 product-specific drug guidances -- 42 new and 12 revised -- on Thursday (Sept. 13), saying the guidances will encourage generic drug development and increase patient access to generic and complex drugs, including those that currently lack competition.

September 12, 2018 | Daily News

FDA is evaluating the role that e-cigarette flavors play in driving youth use of the products and will factor that into a decision on whether to bump up the compliance deadlines for premarket review, FDA Commissioner Scott Gottlieb announced Wednesday (Sept. 12).

September 12, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Sept. 12) put five major e-cigarette manufacturers on notice that FDA will investigate their sales and marketing practices, including with boots-on-the-ground inspections, to figure out why youth are using and abusing their products.

September 12, 2018 | Daily News

FDA is contemplating moving up the enforcement deadlines for premarket review of e-cigarettes in light of what Commissioner Scott Gottlieb declared is an epidemic of e-cigarette use among teenagers.

September 12, 2018 | Daily News

Two drug industry lawyers, one of whom works for a rare disease-focused nonprofit, have drafted a proposal for FDA to create a rare disease center of excellence similar to the agency’s Oncology Center of Excellence, which was established in 2017.

September 11, 2018 | Daily News

A device industry lawyer said a draft guidance FDA issued Sept. 5 shows the agency is willing to accept greater premarket risk in the device development process, as long as postmarket controls and data collection procedures are in place.

September 11, 2018 | Daily News

FDA published an internal policy laying out how drug center staff should prioritize drug manufacturing facilities for routine current good manufacturing practice (CGMP) surveillance inspections.

September 11, 2018 | Daily News

Device industry and cybersecurity lawyers plan to soon unveil an in-depth report describing a pathway for medical device manufacturers and the wider health care sector to protect against cybersecurity threats.

September 10, 2018 | Daily News

After months of heated stakeholder debate over whether FDA or the U.S. Department of Agriculture (USDA) should regulate cell-based meat, the two agencies announced Monday (Sept. 10) that they will host a two-day joint public meeting to discuss oversight of the nascent industry, with a focus on the potential hazards, regulatory issues and labeling of the emerging technology.

September 07, 2018 | Daily News

FDA has drafted a revised memorandum of understanding that, for participating states, increases the amount of compounded drugs that can be shipped interstate before being considered an “inordinate amount,” scraps a requirement that states act against compounders that distribute inordinate amounts of drugs and offers states new flexibility to gather information on compounders who distribute inordinate amounts of drugs, FDA Commissioner Scott Gottlieb said Friday.

September 07, 2018 | Daily News

FDA floated a number of possible ways to avert drug shortages as it announced plans to hold a public meeting Nov. 27 to gather stakeholders' advice on how the federal government could step in without negatively affecting health care financing and delivery.

September 06, 2018 | Daily News

FDA has launched a new pilot program intended to make the premarket submission process for medical devices more efficient by allowing applicants to use electronic forms to structure their submissions.

September 05, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced two major health care payors joined an agency program to shorten the time between approval of new medical devices and private coverage decisions for those devices.

August 31, 2018 | Daily News

An industry lawyer said a Missouri law enacted this week to limit the use of the word “meat” on food sold in the state to traditional animal products ramps up the regulatory uncertainty facing cell-based meat producers, who are working to develop foods resembling meat, poultry and seafood that are produced using small amounts of cells from the animal the food product is supposed to resemble.

August 31, 2018 | Daily News

A guidance policy issued by the Department of Justice (DOJ) in November 2017 and then reiterated in a DOJ memo in January has provided industry lawyers a potential new tool to fight FDA enforcement action brought against a company using guidance documents as the basis for enforcement.

August 30, 2018 | Daily News

FDA unveiled a pilot program Wednesday (Aug. 29) that will allow qualifying sponsors to meet with agency staff to discuss the use of complex innovative trial design approaches in medical product development.

August 29, 2018 | Daily News

FDA will scrap a 2014 guidance document on pain drug development and replace it with four, less-onerous guidance documents over the next six to 12 months in a bid to spur drug development, FDA Commissioner Scott Gottlieb says in a Wednesday (Aug. 29) statement.

August 28, 2018 | Daily News

FDA has sent warning letters to four online networks operating 21 websites for illegally marketing unapproved, misbranded opioids, including tramadol, the agency announced Tuesday (Aug. 28).

August 24, 2018 | Daily News

The American Clinical Laboratory Association (ACLA) and AdvaMedDx are raising concerns with a draft legislative proposal floated by FDA on Aug. 6 that would overhaul federal regulation of diagnostics, including laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs). ACLA asks lawmakers to reject the proposal in its entirety, while AdvaMedDx calls for more discussion on the plan.

August 23, 2018 | Daily News

FDA has contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a consensus study and issue a report on what evidence is needed to ensure clinical practice guidelines for opioid prescribing for acute pain are sufficient and how to generate said evidence, agency head Scott Gottlieb announced Wednesday (Aug. 22).

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