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Gottlieb's FDA

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).

August 22, 2018 | Daily News

The Trump administration is touting its efforts to increase generic competition as a key achievement of its push to lower drug prices, but Chip Davis, the head of the generic lobby, tells Inside Health Policy that simply increasing the number of generics approved isn't enough to lower prices.

August 22, 2018 | Daily News

FDA and Duke University's Margolis Center for Health Policy will host a public meeting with health care providers and health system stakeholders to explore ways to reduce barriers to evidence-based care for opioid use disorder (OUD), the agency announced Tuesday (Aug. 21) in the Federal Register.

August 20, 2018 | Daily News

Sen. Edward Markey (D-MA) is calling for an overhaul of FDA's safety protocols for transmucosal immediate-release fentanyl (TIRF) products, pointing to data suggesting the agency has known that its current Risk Evaluation and Mitigation Strategies have allowed widespread off-label prescribing of the risky opioid product.

August 17, 2018 | Daily News

The National Institutes of Health and FDA are taking steps to streamline their oversight of gene therapy by limiting the role of NIH and its Recombinant DNA Advisory Committee (RAC) in overseeing human gene transfer (HGT) clinical research protocols.

August 17, 2018 | Daily News

An industry lawyer said FDA’s recent technical assistance (TA) on a diagnostics regulation reform bill does far more than provide technical comments, and instead proposes an entirely new legislative framework that would shake up the agency’s 42-year-old diagnostic premarket review process.

August 16, 2018 | Daily News

FDA announced Thursday (Aug. 16) it has approved the first generic copying Mylan’s EpiPen and held up the announcement as a victory in lowering drug prices, although it was not immediately clear how much cheaper the new generic would be.

August 16, 2018 | Daily News

An industry lawyer said a newly proposed list of device accessories that FDA thinks could be re-classified as low-risk does not fully embrace requests from industry and a directive from Congress to reduce the regulatory burden related to certain device accessories.

August 16, 2018 | Daily News

A veterinary pain management expert is concerned about potential lack of access to opioids in the veterinary medicine space that could be caused by attempts to curb the opioid epidemic.

August 16, 2018 | Daily News

FDA has put veterinarians who prescribe opioids to treat pain in animals on notice that pain medications prescribed for pets could be misused by people.

August 15, 2018 | Daily News

FDA now will make it easier for companies to obtain the review documents the agency uses when it decides not to approve certain tobacco products based on a lack of evidence of substantial equivalence to a predicate tobacco product, the agency announced Tuesday (Aug. 14).

August 14, 2018 | Daily News

Advocates for the use of homeopathic products are urging FDA to back off its plan to step up oversight of the industry, which has largely gone unregulated for the past 80 years.

August 10, 2018 | Daily News

FDA approved Friday (Aug. 10) a first-of-its-kind infusion drug, Alnylam Pharmaceuticals' Onpattro, which treats a rare disease by silencing a portion of a patient’s genes.

August 10, 2018 | Daily News

FDA issued draft guidance Friday (Aug. 10) intended to help streamline the drug development process for cancer drugs and biological products by providing sponsors with advice on how they can design and conduct seamless clinical trials, which allow drug developers to conduct one continuous trial and avoid the stops and starts associated with traditional three-phase trials.

August 09, 2018 | Daily News

Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical tests from premarket review.

August 09, 2018 | Daily News

Following years of debate on the issue, FDA is floating a legislative proposal that would cement the agency's authority to regulate high-risk clinical laboratory diagnostics – including laboratory-developed tests and in-vitro diagnostics – under a risk-based framework in which lower-risk tests could go through FDA's new, voluntary precertification pathway.

August 06, 2018 | Daily News

FDA in a draft guidance published Monday (Aug. 6) lays out new types of endpoints -- beyond complete abstinence from drug use -- that can be used to develop and assess the efficacy of medication-assisted treatment (MAT) for opioid use disorder and be included on product labeling.

August 03, 2018 | Daily News

FDA released the first of what will be two draft guidances aimed at facilitating the development of orally inhaled nicotine-cessation products, like e-cigarettes and other electronic nicotine delivery systems (ENDS), that would go through FDA's approval process for nonprescription drug products sold over-the-counter, instead of being approved by the tobacco center.

August 03, 2018 | Daily News

Key questions loom regarding FDA's plan to offer select sponsors of opioid treatment and prevention devices special treatment in the review process, including what reimbursement pathways may be available, how many sponsors FDA will select and how the streamline review approach will differ from the breakthrough designation.

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