Drugs
FDA has released a draft guidance on “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention,” which addresses the agency’s current thinking on the overall development program and clinical trial designs for systemic drugs administered to kidney transplant recipients to support an indication of prevention of delayed graft
Drugs
A Massachusetts federal court jury has found former New England Compounding Center co-owner Barry Cadden guilty of racketeering and other charges in a 2012 fungal meningitis outbreak that killed more than 60 people and sickened hundreds more nationwide. The Boston Globe reports that the jury returned guilty verdicts on
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says two proposed FDA studies on consumer and healthcare professional identification of false or misleading drug promotion appear to offer little practical usefulness. The association’s comment letter says that identifying deceptive promotion is FDA’s assigned responsibility and not the duty of
Devices
FDA says it has launched a Web site to promote advancement of infectious disease next generation sequencing (ID-NGS) technology. CDRH says that next generation sequencing may allow the diagnosis of infections without prior knowledge of disease causes. “Using ID-NGS technology, each microbial pathogen may be identified by its
FDA Policy/General
Federal Register notice: FDA has announced a two-day (4/4-5) public conference entitled “FDA CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Generic Drugs Forum.” The conference is intended to provide information on the key aspects of the generic drug development process. It will
Drugs
FDA testimony delivered by CDER director Janet Woodcock during a 3/22 House Energy and Commerce Committee health subcommittee hearing on reauthorizing the Prescription Drug User Fee Act (PDUFA 6) indicated that the Trump Administration does not stand behind the agency- and industry-negotiated user fee agreements and that new
Drugs
A 6/1-6/10/16 FDA inspection at USV Private Limited, Daman, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/10 Warning Letter. Specific violations include: * failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards,
Drugs
A 5/30-6/1/16 FDA inspection at Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City (Jinan), China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a just-released 2/24 Warning Letter. Specific deviations included: * failure of the firm’s quality
Devices
FDA says it agrees with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. In an update, the agency says that at this time, most data suggest that BIA-ALCL occurs more
Drugs
FDA has approved a Newron Pharmaceuticals NDA for Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s therapy is not working well, and thus causing
Drugs
A Health Affairs online post by California Western School of Law professor Robert Bohrer calls for a conditional drug approval system that would accelerate access to new drugs while restraining their price until full approval is granted. Bohrer writes that such an approach would address two major issues roiling the
Drugs
FDA has granted NantKwest an orphan drug designation for the company’s activated natural killer (aNK) cell therapy for treating patients with advanced Merkel cell carcinoma. The therapy is currently in a Phase 2 clinical trial at sites in the U.S. treating subjects with metastatic or locally advanced Merkel
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ARK Bio-Medical Canada Corp. North Milton, Prince Edward Island, Canada (3/7): FDA inspected the firm 7/2015 and determined that the firm is marketing the ARK Bio
Drugs
FDA has denied a 4/7/16 ProbioTech petition asking the agency to amend the definition of “dietary supplement” under the Dietary Supplement Health and Education Act of 1994 so that probiotic suppositories could be treated the same as oral probiotic dietary supplements. The company said that if the definition
Drugs
Former FDA commissioner Robert Califf told a 3/14 Clinical Trials Transformation Initiative webinar that better educational efforts are needed so that everyone in the clinical trial chain understands the entire process and not only their own role during a specific trial segment. In a presentation entitled “A Viewpoint on
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension for “Annual Reporting for Custom Device Exemption.” Custom devices are those created or modified in order to comply with an order from an individual physician or dentist. The notice covers annual reporting requirements by manufacturers to FDA about
Drugs
A Mississippi federal court decision in a prescription drug preemption case has muddied the waters for the legal status of design defect as a claim under state law, according to a blog post by attorney Eric Alexander (Reed Smith). He writes that the judge dismissed without prejudice the design defect
Drugs
Tarrex Biopharma has submitted an IND for TX803, a novel treatment for colorectal cancer. TX803 is a first-in-class small molecule therapeutic that “inhibits the PI3K/AKT pathway through a novel mechanism – by targeting, not the kinase itself, but a PI3K activating onco-protein, the truncated retinoid X receptor
FDA Policy/General
Federal Register Notice: FDA has delayed until 3/19/2018 the effective date of its final rule on “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses,’” which published on 1/9. FDA has received a
Devices
FDA has cleared a Trovita Health Science 510(k) for its Safe-T Feed device for administering tube feeding formulas. The company says its device is a ready-to-feed pouch offering the first fully-closed system, pre-packaged with complete enteral formulas. It is intended to simplify the tube
Drugs
FDA inspections of dietary supplement makers in 2016 saw an uptick in GMP violations, according to a report by ConsumerLab.com. Last year, the agency inspected 583 dietary supplement manufacturing facilities, with 362 (62%) receiving a Form 483 indicating GMP noncompliance. In comparison, 2015 saw a GMP violation rate of
Drugs
Array BioPharma has withdrawn its recent NDA for binimetinib monotherapy for treating NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer. The company says the withdrawal was based on a discussion with FDA 3/17 that concluded the clinical benefit demonstrated in the Phase 3 NEMO clinical trial