FDA Policy/General
Federal Register notice: FDA has established a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between 4/2 and 9/14 on FDA’s Web site but not presented at a planned 9/20 Pediatric Advisory Committee meeting. The reviews are
FDA Policy/General
Federal Register notice: FDA has announced a 10/24-25 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the agency’s “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The agency is promoting the panel meeting as a review of
Devices
Attorney Bradley Thompson (Epstein Becker Green) says some medical device industry people are concerned about the FDA 9/11 clearance of two Apple products that came one day before a company launch event for the products. Writing in an online post, Thompson says that while the agency’s goal for
Drugs
International Contrast Ultrasound Society (ICUS) has petitioned FDA urging it to remove boxed warnings from ultrasound contrast agents (UCAs) based on current “highly favorable safety data and clinical experience.” The group’s petition cited studies showing that the contrast agents are safe, improve patient care, reduce overall health care costs,
Drugs
A 9/18-10/10/17 FDA inspection at Pharmaceutical Laboratories and Consultants, Addison, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the contract testing laboratory. A just-released 8/29 Warning Letter says similar deficiencies were cited in 2007, 2009, 2012, and
Drugs
FDA has denied a 2/25/09 petition submitted by a physician asking that the agency “recall all vaccines that contain ingredients that have not been shown to be safe.” The agency denial letter says that some of the contentions raised in the petition were substantially similar to those in
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ITG-Medev San Francisco, CA (9/7): FDA inspected the firm in June and cited GMP deficiencies with its device, the Omiderm wound dressing. For example, the firm failed
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 9/1/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting a notice entitled “Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments” that appeared in the 9/11 Federal Register. The notice was published with an incorrect docket number. The correct docket number is FDA-
Drugs
FDA has cleared a WAT Medical 510(k) for its HeadaTerm for treating migraine headaches. The device uses “precision transcranial electrical stimulation technology to target the pain receptors in the brain via neuromodulation,” the company says. “By sending a particular frequency of electrical stimulation, pain-relieving hormones like endorphins are
Drugs
Severing FDA’s historical independence from drug economics, commissioner Scott Gottlieb has suggested that new innovative payment/reimbursement mechanisms should be developed to allow drug companies to capture a greater upfront share of the social value of antibiotic drug development. In a 9/14 post, Gottlieb indicated that the agency
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities” (OMB Control Number 0910-NEW). The information collection would support agency-sponsored research. To evaluate nominated substances, FDA has proposed a research study
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA’s efforts to identify alternative or streamlined mechanisms for complying with GMPs for combination products. In comments to an agency notice on the efforts, PhRMA sought additional clarity on certain elements of the mechanisms outlined in the notice, and
Drugs
FDA is hosting a 10/15-16 public workshop to convene a discussion on: 1) methodological approaches that may be used to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in managing a
Drugs
House Republicans last week derailed a Trump-supported amendment to a health care spending bill that would have required drug companies to include prices in their direct-to- consumer advertising. Last month, the Senate passed the bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL)
FDA Policy/General
Federal Register notice: FDA has announced an 11/28 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” The workshop is intended to foster the development and implementation of pathogen reduction technologies for blood components intended for transfusion. It will include presentations and panel discussions by experts from academic institutions,
FDA Policy/General
Guide on Consensus Standards Recognition/Withdrawal Federal Register notice: FDA makes available a draft guidance entitled “Recognition and Withdrawal of Voluntary Consensus Standards.” 09/14/2018 Draft Guide on 510(k) Third-Party Review Program Federal Register notice: FDA makes available a draft guidance entitled “510(k) Third-Party Review
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Recognition and Withdrawal of Voluntary Consensus Standards.” The document identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. It provides information on how parties may request recognition as
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “510(k) Third-Party Review Program.” The document reflects amendments made to the third-party review program by the FDA Reauthorization Act of 2017, which directed the agency to issue draft guidance on the factors that will be used
Devices
FDA has approved a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. This is the first device approved by the agency for this indication in 17 years, a
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Xelpros (latanoprost ophthalmic emulsion) 0.005% for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company says Xelpros is the only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that recommend bioequivalence study designs that are intended to support ANDAs. To view the notice, click here.