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Gottlieb's FDA

February 06, 2019 | Daily News

FDA on Wednesday (Feb. 6) finalized guidance detailing the types of clinical studies and novel endpoints that can be used to support approval of depot buprenorphine products and how sponsors should design efficacy trials.

February 05, 2019 | Daily News

In keeping with the goals of the 21st Century Cures Act, FDA on Tuesday (Feb. 5) published draft guidance aimed at laying out predictable premarket review pathways for combination products.

February 05, 2019 | Daily News

A group of leading public health organizations and advocates pushed back on one coalition’s attempt to convince President Donald Trump to stop FDA from regulating e-cigarettes, saying the coalition’s efforts are an “orchestrated effort by the tobacco industry and its political allies” to protect industry’s profits.

February 04, 2019 | Daily News

In final guidance released Monday (Feb. 4), FDA lays out how it will apply least burdensome provisions of medical device review to a device’s total product lifecycle, rather than just the premarket phase, while still ensuring devices meet safety and efficacy standards.

February 04, 2019 | Daily News

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

February 04, 2019 | Daily News

FDA will hold a public workshop on May 1 to weigh potential barriers to generic drug development and alternative ways to evaluate product equivalence outside of in vivo bioequivalence (BE) studies, the agency announced in the Federal Register Monday (Feb. 4).

February 01, 2019 | Daily News

FDA’s Leah Christl, head of the agency’s biologics and biosimilars staff in the Office of New Drugs (OND), will leave FDA on Feb. 22, after 16 years of working with the agency, drug center director Janet Woodcock announced in an email to center staff on Friday (Feb. 1).

February 01, 2019 | Daily News

A bipartisan group of 10 first-term House lawmakers wrote a letter to FDA Commissioner Scott Gottlieb on Wednesday (Jan. 30), urging the agency to not allow plant-based products to use dairy terms in their labeling, an issue the agency hopes to resolve as a part of its multi-year nutrition innovation strategy.

January 31, 2019 | Daily News

Former FDA Commissioner Robert Califf said accelerated approvals are causing medication access problems because the drugs often come with high price tags and a dearth of data on their value compared with lower-cost treatments.

January 31, 2019 | Daily News

A pair of former FDA commissioners debated whether FDA should take the lead on using real-world data and real-world evidence to determine the actual value of drug therapies and in turn ensure the value translates to affordable prices.

January 31, 2019 | Daily News

Experts in the antibiotic and medical device industries say FDA’s recent guidance for device and antibiotic makers on how to coordinate antibiotic susceptibility test (AST) development addresses a niche problem that should encourage more interest in antibiotic development.

January 29, 2019 | Daily News

An FDA official on Tuesday (Jan. 29) told a group of stakeholders that legacy medical devices remain an “intractable challenge” for promoting cybersecurity in the medical device space, a view also held by agency chief Scott Gottlieb who, on the same day, stated that one of FDA’s most critical challenges lies in addressing safety risks posed by the devices.

January 28, 2019 | Daily News

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

January 28, 2019 | Daily News

FDA is taking new steps to advance the use of real-world evidence and real-world data in the digital technologies and drug product labeling space, agency chief Scott Gottlieb announced Monday (Jan. 28).

January 28, 2019 | Daily News

In comments to the agency, two health advocacy organizations urge FDA to partner with other federal agencies to address youth e-cigarette and tobacco product use and addiction.

January 25, 2019 | Daily News

An FDA advocacy group is stumped as to how FDA will resume operations and receive funding from Congress after President Donald Trump agreed on Friday (Jan. 25) to reopen the federal government for three weeks.

January 24, 2019 | Daily News

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

January 24, 2019 | Daily News

FDA issued two draft guidances on Thursday (Jan. 24) that lay out a framework for drug and biologic companies to evaluate their risk management programs, one describing how to develop an assessment plan and the second proposing ways to gauge patient or health care provider knowledge.

January 24, 2019 | Daily News

As FDA and Congress take steps toward enhancing reliance on over-the-counter and nonprescription medicine, the OTC drug lobby group, Consumer Healthcare Products Association, continues to advocate for passage of OTC monograph reform legislation, incentivizing OTC drug makers to help spur prescription-to-OTC switches, and oversight of dietary supplements, CHPA President and CEO Scott Melville told Inside Health Policy.

January 23, 2019 | Daily News

Despite opposition from industry, FDA is not budging from its plan to require that drug and biologics makers with a product approved through the accelerated approval pathway disclose that information on the product’s Indications and Usage section and include a statement explaining that continued approval may be subject to additional trials to confirm the drug’s clinical benefit.

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