FDA Policy/General
A 10/14 New York Times article examines FDA’s and the federal government’s alleged foot-dragging over the last decade that allowed e-cigarette use and marketing to explode to the detriment of teenagers. “In dozens of interviews, federal officials and public health experts described a lost decade
Drugs
FDA has accepted for review an Ultragenyx Pharmaceutical NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders, a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy. The company says UX007 is a “highly purified, pharmaceutical-grade, medium-
Devices
FDA has cleared an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory devices designed to support and expand clinical use of its patient-specific cranioplasty implant already cleared by the agency. The new accessories are intended to assist neurosurgeons
Drugs
FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that led to the recall of several common blood pressure medicines known as sartans. Earlier this year, FDA temporarily increased the allowable level of the chemical while it undertook the review. A new analysis
Devices
FDA has cleared a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air. The device, according to the company, features 69 laser diode terminals that generates a laser treatment that is evenly spread on the scalp to activate follicle cell proliferation, increase blood flow,
FDA Policy/General
CDRH Listing on Upcoming Guidance Documents Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. 10/11/2019 Info Collection on 510(k) 3rd-party Reviews Federal Register notice: FDA submits
FDA Policy/General
DEVICES FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for
FDA Policy/General
Federal Register notice: FDA has announced its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. In addition, FDA has established a docket where comments are being accepted on prioritizing topics for guidance development. One listing outlines
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “510(k) Third-Party Review Program” (OMB Control Number 0910-0375). The program permits FDA to accredit persons in the private sector to review certain 510(k)s. A third party wishing to participate needs to submit
Drugs
Innoveix Pharmaceuticals has recalled all sterile compounded drug products due to sterility assurance concerns. Affected products are injectable human chorionic gonadotropin and injectable sermorelin with growth hormone-releasing peptide-2, according to a recall notice. Administering a drug product that is not sterile could result in serious infections, which may
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance for Industry on Registering with the Center for Veterinary Medicine’s (CVM) Electronic Submission System — 21 CFR 11.2OMB” (Control Number 0910-0454). CVM has placed notifications in a docket identifying documents acceptable for electronic submission
Drugs
FDA has issued a highly redacted 38-page Form-483 following an inspection at drug manufacturer Cipla in Goa, India, that concluded 9/27. For example, the first 11 pages cited the company over its equipment and utensil cleaning. FDA also cited Cipla for its aseptic processing areas being deficient,
Drugs
FDA has approved Eli Lilly’s Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults. Approval was based on data from two placebo-controlled clinical trials involving almost 3,200 adults with a history of migraines. “In both studies, the percentages of patients whose
Devices
FDA has cleared a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty. The robotic device includes CT-based 3D pre-surgical planning software which “allows the surgeon to design and prepare, in a virtual environment, the patient’s unique knee joint
Drugs
A new study in JAMA suggests there is limited feasibility for the the idea of replicating clinical trials using real-world evidence (RWE). Researchers from numerous academic centers and industry examined clinical trials with human participants that were published in high-impact journals in 2017 and found “only 15% of
Drugs
FDA has cleared a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing. The company says the single-use, sterile, antimicrobial gauze dressings are impregnated with Hexagen, Turn’s petrolatum-based wound care emulsion. Its broad-spectrum antimicrobial provides protection against bacteria, fungi, and yeasts, it says.
Drugs
There are seven inspection observations on the FDA-483 released by the agency following a 9/19-9/27 inspection at the Aurobindo finished drug manufacturing facility in Telangana, India. The observations were: * failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components
Drugs
FDA has released the FDA-483 issued following a 9/16-9/20 inspection at the Lupin API manufacturing facility in Maharashtra, India. The three inspection observations on the form were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed; * batch production and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0827). Outsourcing facilities are required to register with FDA and submit regular
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings-Labeling Considerations.” The document addresses labeling for devices containing lubricious coatings used in the vasculature. It also provides recommendations for information to be included in the device labeling for consistency
Biologics
FDA says its scientists have developed two candidate vaccine viruses that may be used as the starting material for producing inactivated influenza vaccines. The candidate vaccine viruses protected lab animals against a highly pathogenic strain of Influenza A (H7N9), a potentially pandemic virus, an agency statement says. The candidates are
Devices
FDA has cleared a Sky Medical Technology 510(k) for its geko device for stimulating the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE). Previously, the device was cleared for immediate post-surgical stimulation of calf muscles to prevent VTE, increasing blood