FDA Policy/General
Federal Register notice: FDA has announced the availability of its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” The report shows that an average of 264 postmarketing requirements (PMRs) were established each year since FY 2011. Most PMRs that were
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. It is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees for which vacancies currently exist or
FDA Policy/General
Federal Register notice: FDA has published a list of PMAs and humanitarian device exemption applications that have been recently approved. The listing serves to inform the public about the availability of related safety and effectiveness summaries through the Internet and the agency’s Dockets Management staff. To view the listing,
Drugs
FDA is seeking to eliminate the use of dogs in clinical research by animal drug developers. The agency says it will propose a study that, once completed, could help establish a non-animal based model that will “potentially replace much of the need to use dogs in future trials with
Devices
Three King & Spalding attorneys say the “unavoidably unsafe” exception in a comment in a section of the Restatement (Second) of Torts should be categorically applied to all medical devices. Writing in a Washington Legal Foundation (WLF) Legal Opinion Letter, the attorneys say the Utah Supreme Court will soon have
Drugs
The American Medical Association (AMA) 2018 interim meeting has adopted a report saying that letting Americans import prescription drugs in person from licensed Canadian brick-and-mortar pharmacies could improve cost-sharing levels and address a major barrier to medication adherence. An AMA statement says Canadians spend about half the
FDA Policy/General
Federal Register notice: FDA has announced three public meetings entitled “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonization (ICH) E2B(R3) Standards.” The meetings are intended to provide the pharmaceutical industry and other interested parties with information on the plans,
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate
Devices
FDA says Oscor has expanded its 9/29 recall for certain lots of TB Unshrouded Bipolar Pacing Leads to include expired inventory for devices distributed between 12/21/11 and 5/17/18. A company recall notice posted by FDA says the expansion is to ensure proper disposition of expired
Drugs
FDA has granted Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with CHP (cyclophosphamide, doxorubicin, and prednisone). The designation
Devices
FDA says the GE Healthcare Millennium Nuclear Medicine Systems recall is Class 1. GE says the devices are used to take images of a patient’s organs or tissues to help diagnose or treat a health condition or disease. The systems are intended for use as diagnostic imaging devices that
Drugs
Agreeing with points made in a Pfizer 8/22 citizen petition, Novartis says FDA needs to do more to promote biosimilars and counter a communication campaign that it says is spreading false information about the products. The company’s comment letter acknowledges steps FDA and HHS have taken to increase
Drugs
FDA Office of Communications associate director for research and risk communications Paula Rausch says the agency is identifying and analyzing online and social medical conversations as part of a broad, systematic approach to monitoring drug use and abuse trends in society. In a CDER Conversation, Rausch says the data gathered
Drugs
A joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 10 to 7 to recommend approval of Mallinckrodt subsidiary SpecGx’s investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for managing pain severe enough
Drugs
PharmaCyte Biotech says it has completed an FDA-required formal report on safety studies using a pig model that were undertaken before getting the agency to sign off on the first clinical trial in humans using its cellulose-based capsules that contain live genetically altered cells which activate the anticancer
Drugs
FDA has released the FDA-483 issued following a 10/22-10/30 inspection at Dr. Reddy’s Laboratories, Visakhapatnam, Andhra Pradesh, India. The inspection observations were: * failing to have written procedures for production and process controls to assure that drug products have the identity, strength, quality, and purity they
FDA Policy/General
Federal Register notice: FDA has announced a 2/4 public workshop entitled “Evaluating the Pressor Effects of Drugs.” The workshop is intended to bring the stakeholder community together to discuss the premarketing assessment of a drug’s effect on blood pressure. FDA says that elevated blood pressure is known to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.” This form of cancer is defined by rising prostate-specific antigen (PSA) despite castrate levels of testosterone and no radiographic evidence of distant metastatic disease.
Drugs
Seven samples of dietary supplements intended to improve memory were tested by a qualified laboratory and did not contain their stated ingredients in the stated quantity, according to a report from the Government Accountability Office (GAO) to two Democratic senators. The report says the senators asked GAO to examine the
Drugs
FDA has approved Stallergenes Greer’s Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) for treating patients aged five to nine years with grass pollen-induced allergic rhinitis. Previously, the sublingual tablet was approved for treating patients aged 10 to 65 years. In
Devices
FDA has cleared a Canon Medical Systems 510(k) for its new premium MRI system, Vantage Orian 1.5T. The device features Rapid Scan technologies to reduce scan time, a dockable table to assist in seamless patient handling, and low energy consumption to minimize running costs, the company says. It
Devices
FDA has released three documents produced by the International Medical Device Regulators Forum, of which the agency is a member. Optimizing Standards for Regulatory Use says that standards play a significant role in the design, production, post-production, and regulation of medical devices throughout their lifecycle. “Standards offer a means