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Gottlieb's FDA

January 19, 2018 | Daily News

FDA's drug center released Friday (Jan. 19) its 2018 guidance agenda, which includes new categories focused on over-the-counter (OTC) drug development and rare diseases.

January 18, 2018 | Daily News

Bipartisan legislation that would launch an over-the-counter (OTC) user fee program coupled with monograph reform cleared the House Energy & Commerce health subcommittee Wednesday (Jan. 17) by voice vote, despite lawmakers grappling with a provision providing two years of exclusivity to innovative OTC drugs.

January 18, 2018 | Daily News

FDA has clarified through guidance the details of its newest voucher program, which was established through the 21st Century Cures Act and is intended to incentivize sponsors of material threat medical countermeasure (MCM) products -- those that diagnose, prevent or treat illness caused by chemical, biological, radiological and nuclear threats and emerging infectious diseases -- by expediting their review.

January 17, 2018 | Daily News

A bill that would allow drug and device manufacturers to communicate off-label information about their products with payers cleared the House Energy & Commerce health subcommittee on Wednesday (Jan. 17), despite Democratic opposition.

January 12, 2018 | Daily News

FDA announced on Friday (Jan. 12) that it will continue to delay until further notice a controversial regulatory measure that would factor “the totality of the evidence” into agency decisions regarding a drug or device manufacturer's intended use of a product and communications about such uses.

January 12, 2018 | Daily News

The House Energy & Commerce oversight subcommittee will hold a hearing Friday (Jan. 19) on FDA’s handling of food recalls. The hearing will discuss a recently released report by the HHS Office of Inspector General, which identified key flaws in FDA’s response to food borne outbreaks.

January 12, 2018 | Daily News

FDA and the Centers for Disease Control and Prevention are under fire for an alleged lack of transparency with the public after the agencies declined to warn consumers that romaine lettuce may be the source of an E. coli outbreak.

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 11, 2018 | Daily News

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

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.

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