Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
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.
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in patent and exclusivity information, product quality assessments and bioequivalency data, the agency says in draft guidance published Wednesday (Jan. 3).
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).
Legal experts representing the clinical decision support (CDS) software industry take strong issue with FDA's draft guidance on CDS software, published Dec. 7.
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.
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.
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).
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.
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.
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.
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