FDA Policy/General
BIOLOGICS Comments Sought on BLAs, Postmarketing Reports Federal Register Notice: FDA is seeking public comment on the collection of information relating to general licensing provisions for BLAs, changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h. Form 356h is the “Application to
Drugs
Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI), which is recognized by the UK government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements, including the pricing scheme for medicines in the UK. The
Drugs
Senators Dianne Feinstein (D-CA) and Chuck Grassley (R-IA), have co-introduced the Cannabidiol Research Expansion Act, a bill to support research initiatives on the potential benefits of substances like cannabidiol (CBD) that are derived from marijuana. “I strongly believe that more research into the potential medical benefits of
Drugs
FDA reviewers say data contained in a Valeant Pharmaceuticals BLA for Siliq (brodalumab) injection for treating adults with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy showed that the therapy was superior to placebo in reducing psoriasis severity after 12 weeks of treatment. The
Devices
FDA has approved an Abbott Medical Optics PMA for what the agency describes as the “first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.” Traditional monofocal IOLs have been limited
Drugs
FDA has posted the commitment letter (performance goals and procedures) from industry negotiations to reauthorize the Prescription Drug User Fee Act for fiscal years 2018 through 2022. The letter outlines the agency intention to enhance regulatory science and expedite drug development. “To ensure that new and innovative products are developed
Drugs
The House Energy & Commerce Committee has voted out a bill that would establish a new priority review program that would award a voucher to sponsors that develop a “material threat medical countermeasure” product. The voucher would entitle the holder to a priority review for a future NDA submission. The
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product. It is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product
FDA Policy/General
Federal Register Notice: FDA is making available a revised guidance for industry entitled Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. It is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. To download this guidance, click here. To
FDA Policy/General
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in selecting a nonvoting industry representative of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory, notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative and an alternate to
FDA Policy/General
Synergy Pharmaceuticals says it has decided to continue patient enrollment for its two ongoing Phase 3 clinical trials with plecanatide in irritable bowel syndrome with constipation (IBS-C), despite trial monitoring showing slower enrollment pace combined with an increase in the number of patients not meeting randomization criteria after the
Devices
FDA has cleared a Medifirst Solutions 510(k) for its Time Machine TTML-8102000 Laser Thermal Therapeutic Device. The Infrared Laser at 810/830nm wavelength is indicated for temporary relief of minor muscle and joint pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by
Drugs
The Government Accountability Office (GAO) says that to help address drug shortages, FDA prioritized review of 383 drug applications and supplements between calendar years 2010 and 2015. Most were for generic sterile injectable drugs. “FDA’s approval of some of these submissions occurred before the shortage was resolved,” a new
Drugs
The latest Tufts Center for the Study of Drug Development Impact Report reviews the burgeoning regenerative medicine (RM) market worldwide and the differing regulatory approaches taken in the U.S., Europe, and Japan. The report (subscription required) says that FDA does not plan to establish a separate regulatory pathway for
Drugs
FDA has issued a draft guidance, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, as a “how-to” supplement to an earlier final guidance that defined in vitro companion diagnostic (IVD) devices and set an expectation that companion diagnostics and corresponding therapeutic products should
Drugs
FDA has told Santhera Pharmaceuticals that its planned clinical trial for Raxone (idebenone) in Duchenne muscular dystrophy (DMD) patients will not support an accelerated approval pathway, but it will support, if the results are positive, a traditional NDA approval route. The company had proposed an accelerated approval pathway using its
Drugs
CDER director Janet Woodcock, celebrating 30 years with FDA, says that in the next 30 years the pace of change will accelerate and there will be a splintering of diseases into molecular subtypes. Interviewed for an agency Director’s Corner podcast, Woodcock predicts that placing diseases in molecular subtypes will
Drugs
The DC federal court has granted FDA summary judgment in a case brought by Boehringer Ingelheim involving a dispute over the agency’s interpretation of the legal reference to the date that a drug application is initially submitted for an approved drug product. The company brought suit to resolve the
Drugs
Virtus Pharmaceuticals is asking that FDA start proceedings to remove two NDAs for potassium chloride oral solution from Lehigh Valley Technologies because the company inappropriately avoided paying $2.2 million in user fees. The petition also asks that the matter be investigated in accordance with the agency’s application integrity
Devices
FDA has approved a Novocure PMA supplement for its second generation Optune system for treating adult patients with histologically-confirmed glioblastoma multiforme. The device features new smaller, lighter Tumor Treating Fields (TTFields) that are less than half the weight and half the size of the generator in the first Optune
Drugs
As FDA prepares to make approval decisions on a slew of ANDAs for generic copies of AstraZeneca’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium), the DC federal court has ordered that it be provided 24 hours notice before any decision is rendered on any ANDA or a related citizen petition
Devices
FDA has cleared a Tandem Diabetes Care 510(k) for the Tandem Device Updater, an Apple (Mac) and PC-compatible tool for remote updates to its Tandem insulin pump software. “The first use of the Tandem Device Updater will be for deployment of the latest t:slim Insulin Pump software