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Gottlieb's FDA

January 09, 2018 | Daily News

In response to comments from food industry stakeholders, FDA won’t subject certain entities and activities to some provisions of the Food Safety Modernization Act (FSMA) that pertain to current good manufacturing practices (CGMPs) and risk-based controls for human and animal food; foreign supplier verification; and produce safety standards for growing, harvesting, packing and holding produce intended for humans, the agency explained in guidance document and press announcement on Thursday (Jan. 4).

January 08, 2018 | Daily News

The leading regenerative medicine trade association is optimistic that the field will continue to rapidly advance in 2018 buoyed by FDA’s rapid acceptance of the field and the deep pipeline of products in development.

January 04, 2018 | Daily News

Despite the approval of multiple biosimilars, industry wins in payment policy and release of highly anticipated FDA guidance, some experts are skeptical that 2018 will be a tipping point for the nascent biosimilar industry, citing issues with payers, lack of final FDA guidance on key issues and litigation backlogs created by late-stage patents.

January 04, 2018 | Daily News

FDA hopes to make the generic drug review process more efficient by addressing “recurring deficiencies” in manufacturers' generic drug applications that may lead to approval delays, including deficiencies in patent and exclusivity information, product quality assessments and bioequivalency data, the agency says in draft guidance published Wednesday (Jan. 3).

January 03, 2018 | Daily News

In the first quarter of 2018, FDA will develop guidance addressing tactics used by branded drug companies to prevent or delay generics from entering the market, including abusing the citizen petition process; restricting access to testing samples of branded drugs; and taking advantage of the single, shared Risk Evaluation and Mitigation Strategies (REMS) negotiation process, FDA Commissioner Scott Gottlieb said Wednesday (Jan. 3).

December 29, 2017 | Daily News

Legal experts representing the clinical decision support (CDS) software industry take strong issue with FDA's draft guidance on CDS software, published Dec. 7.

December 28, 2017 | Daily News

FDA from 2008 to 2014 saw a roughly 500 percent increase in the number of premarket submissions that include patient-reported outcome (PRO) measures, but there are still challenges the agency needs to tackle when it comes to incorporating PROs into device approvals, including enhancing training, transparency and expertise, and reducing sponsor uncertainty, according to the agency's first PRO report released Dec. 12.

December 27, 2017 | Daily News

One lawmaker is upset FDA has yet to provide him details on how the agency will address use of unapproved non-opioid products and off-label uses of non-opioid products for acute and chronic pain treatment.

December 21, 2017 | Daily News

FDA is seeking nominations for patient advocates to participate in a Patient Engagement Collaborative (PEC), which will bring FDA and the patient community together to discuss patient engagement in medical product development and other regulatory issues, the agency announced in the Federal Register on Wednesday (Dec. 20).

December 20, 2017 | Daily News

FDA on Tuesday (Dec. 19) finalized a 23-year process for determining whether certain health care antiseptic drug products are generally recognized as safe and effective (GRASE), issuing a final rule that finds 24 active ingredients are not GRASE for use in OTC antiseptic products and therefore must go through premarket review.

December 19, 2017 | Daily News

FDA is taking action to close an unintended loophole in the Pediatric Research Equity Act (PREA) -- a loophole the agency says has allowed drug sponsors to bypass pediatric study requirements by obtaining an orphan drug designation for a product to be used in pediatric subpopulations even if it is indicated for the same disease that is common in the adult population.

December 19, 2017 | Daily News

FDA approved Tuesday (Dec. 19) Spark Therapeutics' Luxturna (voretigene neparvovec) -- a gene therapy used to treat patients with a rare form of genetically inherited blindness, and the first FDA-approved directly administered gene therapy that targets a disease caused by mutations in a specific gene.

December 19, 2017 | Daily News

Two public health groups are upset over FDA's recent decision to terminate the agency's only food advisory committee, with the Center For Science in the Public Interest calling the decision “further evidence of the low value this administration places on independent scientific advice.”

December 18, 2017 | Daily News

FDA is adopting a risk-based enforcement approach for regulating certain categories of homeopathic drug products that are marketed without FDA approval, the agency announced through draft guidance published on Monday (Dec. 18).

December 18, 2017 | Daily News

FDA Commissioner Scott Gottlieb announced Friday (Dec 15) the agency's intention to work with the U.S. Pharmacopeial Convention to develop standards for drugs that FDA has highlighted as off-patent, off-exclusivity and without generic competition.

December 18, 2017 | Daily News

FDA on Friday (Dec. 15) published guidance for sponsors of targeted therapies, including how to identify patients for clinical trials and how to present the benefits and risks of such therapies.

December 14, 2017 | Daily News

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

December 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices.

December 13, 2017 | Daily News

Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

December 13, 2017 | Daily News

The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition.