FDA Policy/General
ATS Labs, LLC Houston, TX (2/3). GMP deviations, adulterated, misbranded: The firm performs the finished product labeling for Support, Liver Food, Test PSI, LipoBlast, CFI, Winalean, ProFiex, and Lady Lean products, but it stated during the inspection that it does not have specifications for these products. During the inspection
FDA Policy/General
FDA reported 1,036 cybersecurity incidents between 1/2013 and 6/2015, according to a Federal Times report based on information obtained through a Freedom of Information Act request. Some 50% of the incidents were attributed to unauthorized access, while 21% were scans, probes, or attempted access, and 19% were
Drugs
Congresswoman Rosa DeLauro (D-CT) has introduced HR 4565, a bill that would amend the Food, Drug, and Cosmetic Act to restrict direct-to-consumer (DTC) drug advertising. The measure was referred to the House Committee on Energy and Commerce which will consider it before sending it to the House
Biologics
FDA has issued a new guidance recommending blood donor deferrals for those who have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection. “The FDA has critical responsibilities in outbreak situations and has been working rapidly
Drugs
FDA says the following updates have been made to the REMS@FDA approved Risk Evaluation and Mitigation Strategies (REMS) Web site. Changes include: Sanofi Aventis Multaq REMS released 2/12; PF Prism Xeljanz REMS released 2/8; Isotretinoin iPLEDGE shared system REMS modified 2/4 to increase awareness and compliance
FDA Policy/General
BIOLOGICS FDA Seeks Collaborators for Anti-Virus Invention Federal Register Notice: The invention listed in this document: Therapeutic and prophylactic anti-Influenza virus neuraminidase 1 (N1) antibody (CD6) with a novel epitope that spans neuramindase dimers, is owned by an agency of the U.S. government and is available for
Drugs
DEVICES FDA has cleared a Becton Dickinson 510(k) for the BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge for use in testing CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients. The automated multicolor fluorescent imaging cytometer and absorbance spectrometer provides
FDA Policy/General
Federal Register Notice: FDA's collection of information entitled “Request for Samples and Protocols,” has 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’s collection of information entitled “Guidance for Industry on Formal Meetings with Sponsors and Applicants for Prescription Drug User Fee Act Products” has 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: The invention listed in this document: Therapeutic and prophylactic anti-Influenza virus neuraminidase 1 (N1) antibody (CD6) with a novel epitope that spans neuramindase dimers, is owned by an agency of the U.S. government and is available for licensing in accordance with federal regulations to achieve
FDA Policy/General
Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee will meet 4/7, from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss an Intercept Pharmaceuticals’
FDA Policy/General
Federal Register Notice: FDA and the Pharmaceutical Users Software Exchange will hold a public conference 3/13-15 entitled “The FDA/PhUSE Annual Computational Science Symposium” to help the broader community align and share experiences to advance computational science. FDA will update participants on current initiatives, and collaborative project groups
FDA Policy/General
Federal Register Final rule: FDA is removing two regulations that prescribe procedures for the agency’s review and classification of biological products licensed before 7/1/72. It is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments Class 3 device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to Class 2 (special controls) in patients with acute
FDA Policy/General
Federal Register Final order: FDA is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the Unite3D Bridge Fixation System, a 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery. The company says its OsseoTi porous metal technology mimics the architecture of cancellous bone and the Unite3D serves as
Drugs
FDA has posted two draft guidances on developing drug products for allergic and non-allergic rhinitis. The first guidance, “Allergic Rhinitis: Developing Drug Products for Treatment,” addresses issues of trial design, effectiveness, and safety for new products being developed for treating seasonal allergic rhinitis and perennial allergic rhinitis. The second
Drugs
FDA has denied an Allergan citizen petition that had asked the agency not to approve ANDAs for Restasis (cyclosporine ophthalmic emulsion) unless certain conditions are met. The petition had asked that FDA, among other things, not approve such ANDAs if they only contain in vitro demonstrations of bioequivalence. In its
Drugs
Just weeks away from CDRH completing a safety review of Bayer Health’s controversial Essure permanent birth control device, Rep. Mike Fitzpatrick (R-PA) now is planning to release investigation findings 2/17 to expose unreported deaths caused by the device and complaints alleging illegal kick-backs from the manufacturer
Devices
FDA has cleared an Optovue 510(k) for the AngioVue Imaging System, a dyeless technique for quickly visualizing abnormal blood vessels in the retina to help physicians determine an appropriate treatment course. “In less than three seconds, the AngioVue System acquires a single image that complements the current angiography imaging
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
Drugs
Sen. Joe Manchin (D-WV) has introduced the “Changing the Culture of the FDA Act,” a bill that would expand the agency’s mission statement to require it to address the nation’s opioid epidemic. Manchin says that FDA plays a critical role in the growing opioid epidemic through its