Drugs
FDA Webview has posted the court-approved consent decree between FDA and Philips North America that prohibits manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation business unit at facilities in Andover, MA, and Bothell, WA, until they comply with agency regulations
Devices
Abbott Quality & Regulatory says a draft FDA guidance on “Deciding When to Submit a 510(k) to an Existing Device” interprets a “major change in intended use” to be a type of change that “could significantly affect safety or effectiveness,” which is inconsistent with current regulatory language. In its
Drugs
FDA has accepted a Bayer BLA for BAY94-9027, an extended half-life PEGylated recombinant human Factor VIII compound for treating hemophilia A in adults and adolescents 12 years of age and older. The submission is based on data from the PROTECT VIII pivotal Phase 2-3 trial that was
FDA Policy/General
Federal Register notice: FDA is seeking nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committee. Nominees may either be self-nominated or nominated by an organization. Nominations received on or before 12/4 will be given first consideration for membership on the panel. To view the
FDA Policy/General
Federal Register notice: FDA has announced an 11/30 public meeting on “Assessment of FDA Hiring and Retention” that will share high-level findings from a recently completed examination of the agency’s hiring process conducted by an independent contractor. It will also outline actions FDA will or can take
Devices
During a recent FDA Webinar on an agency final guidance on design considerations and premarket submission requirements for interoperable medical devices, CDRH senior science health advisor Heather Agler said the agency suggests that companies design systems with interoperability as an objective. “Think about this upfront when you’re thinking about
Drugs
FDA has approved a Bausch + Lomb and Nicox NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), indicated for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The once daily therapy has a dual mechanism of action, according to the company, and works by metabolizing into
Devices
A Massachusetts federal judge has entered a consent decree of permanent injunction sought by FDA against Philips North America and two of its officers, generally prohibiting them from manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation (ECR) business unit at facilities
FDA Policy/General
Federal Register notice: FDA has made available an International Council for Harmonization draft guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The document is intended to clarify, update, and extend the earlier ‘‘E9 Statistical Principles for Clinical Trials’’ in two main
FDA Policy/General
Federal Register notice: FDA has announced a 12/11-12 public workshop on “Packaging, Storage, and Disposal Options To Enhance Opioid Safety — Exploring the Path Forward” that will host a scientific discussion on the role of packaging, storage, and disposal options in order to curb inappropriate access to prescription opioid
Drugs
FDA has denied a 2/26/16 Empire State Consumer Project (ESCP) petition asking that it test all brands of OTC and prescription drug products containing polyethylene glycol 3350 (PEG 3350) for the presence of selenium, determine the source of any selenium found in the tested products, and issue a
Drugs
FDA has denied a Pharmaceutical Manufacturing Research Services (PMRS) 5/11 petition to stay the effective date of the approval of Inspiron’s Roxybond (oxycodone hydrochloride) with labeling claims pertaining to chronic use and abuse deterrence until the agency issues substantive written responses to two earlier PMRS petitions. The denial
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension on the “Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.” The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance
FDA Policy/General
FDA has sent Warning Letters to four companies that marketed marijuana-derived products as cancer treatments. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been
Drugs
Pfizer officials say they have submitted a corrective and preventative action plan to FDA on remediating GMP issues at Hospira legacy facilities, and significant progress is expected in 2018. Pfizer acquired Hospira in 2015 and it has struggled to bring troubled facilities into GMP compliance. Earlier this year, FDA sent
Drugs
In a 54-page report, the Lancet Oncology Commission builds on the work of the Cancer Moonshot blue ribbon panel to lay out a series of future research priorities. “To ensure that cancer research in the U.S. continues to be world-leading,” it says, “it is imperative that investment
Drugs
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-1 on 10/31 to recommend approval of Indivior’s RBP-6000 for treating opioid use disorder. The product is described as an investigational once-monthly injectable buprenorphine formulation in the Atrigel
Drugs
FDA has cleared a Luminex 510(k) for the ARIES Group A Strep Assay for detecting Streptococcus pyogenes from throat swab specimens using the ARIES System. The real-time polymerase chain reaction-based qualitative in vitro diagnostic test, is part of Luminex's respiratory testing menu that includes the
Devices
The 510(k) Coalition says in a comment letter that an FDA draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device,” exemplifies a strong step forward in clarifying and defining the process for when a modification would trigger a new 510(k)
Biologics
Novartis has submitted a supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion for treating adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. In August, Kymriah became the first available chimeric antigen receptor T (CAR-T)
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements — OMB Control Number 0910–0770.” The rule requires that firms subject to mandatory reporting requirements submit safety reports in an electronic format that
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.” The document applies to, upon patient request, data from devices that are unique to an individual patient or patient’s treatment or diagnosis that has been recorded, stored,