Drugs
FDA says a Web site operated by Harrington House, Danville, VA, takes orders for seven Abbey St. Clare products that are promoted through claims that establish them as drugs. A 9/2 Warning Letter says that the products are not generally recognized as safe and effective for their intended uses
Devices
A former medical device sales representative for Johnson & Johnson was convicted by a Florida federal court jury on seven felony counts of conspiring to transport stolen medical devices in interstate commerce, money laundering, and other charges. The Department of Justice says that the conviction of Kerri Kaley arose out
FDA Policy/General
FDA is looking for public input on its efforts to mitigate antimicrobial resistance by focusing for the first time on medically important antimicrobials used to treat human disease that are placed in animal feed or water that have at least one therapeutic indication without a defined duration of use. A
FDA Policy/General
Federal Register notice: FDA has released a guidance on “Qualification of Biomarker — Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease (COPD).” The document provides a qualified context of use for plasma fibrinogen in COPD interventional clinical trials for patients at
Drugs
CDER says it will develop a guidance this year on “Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA.” The Center disclosed the new guidance in a periodic update to its Guidance Agenda. Combination product review processes and procedures have recently been getting
Biologics
FDA has posted a guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” that provides recommendations for testing living donors using an FDA-licensed donor screening test.
Devices
FDA has approved an Obalon Therapeutics PMA for the Obalon Balloon System, a nonsurgical, reversible device for weight loss. The swallowable intragastric balloon device is indicated for temporary use to facilitate weight loss in adults with obesity who have failed to lose weight through diet and exercise. It is intended
Devices
Novocure says a long-term survival analysis of data from a Phase 3 (EF-14) trial of Optune in combination with temozolomide confirms superior progression free and overall survival in newly diagnosed glioblastoma multiforme (GBM) patients. “The long-term analysis shows survival rates were significantly higher four years from randomization
Drugs
The Washington DC District Court has ruled against FDA in granting a Ferring motion for reconsideration over how FDA decided not to retroactively apply a 2014 interpretation on five-year new chemical entity (NCE) exclusivity awarded to certain fixed-combination drug products (see earlier story). An agency guidance outlined the
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register notice: FDA has released a draft guidance on “510(k) Third Party Review Program” that provides current thinking and proposes to harmonize with elements from the International Medical Device Regulators Forum’s regulatory assessment program called the Medical Device Single Audit Program. In addition, it describes criteria to
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee. The committee advises the agency in discharging responsibilities related to the regulation of tobacco products. The committee also reviews and evaluates safety, dependence, and health issues relating to tobacco products and
Drugs
FDA reviewers say they identified concerns with the “ascertainment of the primary neuropsychiatric adverse event outcome that impacts interpretation” of an agency-required postmarketing trial which evaluated neuropsychiatric adverse effects in patients taking Pfizer’s Chantix (varenicline) and GlaxoSmithKline’s Zyban (bupropion). Pfizer has submitted a supplemental NDA that seeks
FDA Policy/General
BIOLOGICS Blood Products Panel to Meet Federal Register Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New
Drugs
FDA has granted BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer. The company currently is preparing an IND, with plans to begin a U.S. clinical trial next year. The active ingredient in BIV201 is a potent vasoconstrictor, and its mechanism of
Devices
GE Healthcare has gained 510(k) clearance for MAGiC (Magnetic Resonance Image Compilation), which is a customized version of SyntheticMR’s SyMRI Image software marketed by GE Healthcare under a license agreement. The multi-contrast technique is intended to give clinicians more data than conventional scanning in a fraction of
Devices
FDA has released a draft guidance on “510(k) Third Party Review Program” that describes harmonization efforts, such as incorporating elements from the Medical Device Single Audit Program into the third-party review program. The document also discusses third-party reviewers’ applications for initial recognition into the program. Under the
Devices
FDA has posted a one-page Form-483 from an inspection last month at troubled blood diagnostic firm Theranos, based in Palo Alto, CA. The agency cited the firm for performing clinical investigations prior to obtaining IRB approval. Presumably, the inspection document is related to the company’s decision to
FDA Policy/General
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Health Document Submission Requirements for Tobacco Products. It is intended to assist persons making certain document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. The revised draft guidance includes guidance
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional Clinical Trials. It was prepared under the auspices of the International Council for Harmonization. Multi-regional clinical trials (MRCTs) conducted according to the guidance will investigate treatment effects in
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center,
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) 11/1, from 8 a.m. to 5:30 p.m., and 11/2, from 8 a.m. to 11:40 a.m. at the Crowne Plaza Hotel, 201