Devices
FDA’s Circulatory System Devices Panel has voted 9-0 to recommend approval of an Abbott PMA for the first fully absorbable drug eluting stent. Agency reviewers had determined that clinical data submitted showed that the device was not inferior to a traditional stent, according to a briefing document released
Drugs
Four Faegre Baker Daniels attorneys say that two recent decisions involving Alcon and Lilly demonstrate that it may be difficult for branded drug companies to prevent a litigation stay in view of pending inter partes review (IPR) proceedings. (Inter partes review is a procedure to challenge a patent’s validity
Drugs
A 3/14 FDA draft guidance explains how the agency will implement Biologics Price Competition and Innovation Act (BPCIA) provisions for moving protein products currently approved under the drug statute to the biologics system. The BPCIA requires that as of 3/23/20, all NDAs and ANDAs for protein products
Devices
A 10/26-11/10/15 FDA inspection at Sure Tek Medical, Greenville, SC, found Quality System Regulation violations in the firm’s manufacturing of medical devices such as orthopedic and laparoscopic instruments. A 3/3 Warning Letter from the agency’s Atlanta District Office says that procedures for monitoring
Devices
CDRH conducted 5% fewer device quality systems (QS) surveillance inspections last year, according to just-posted inspection metrics. The Center conducted 2,104 QS inspections, which is 109 less than in 2014. More foreign inspections were performed in 2015 (620 inspections) than in 2014 (594), which translates to a 4%
Devices
A CDRH safety alert says Olympus has updated reprocessing instructions for its 160F/VF duodenoscope models to include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures, specifically additional flushing, brushing and increased flushing volume. It also recommends a reusable brush (Model MAJ-1534) to
Drugs
CDER says it will require packaging design changes for eye drop bottles that have loose plastic safety seals or tamper-evident rings below the bottle cap because they may fall onto the eye when used. It strongly recommends that the bottle/cap design include a positive-retention mechanism similar to
Drugs
In an amicus brief submitted to the 3rd Circuit Court of Appeals in a case involving a reverse payment from GlaxoSmithKline to Teva to delay entry of generic Wellbutrin XL, the Federal Trade Commission says that a Pennsylvania federal court decision contained four errors and should be overturned. The commission
Drugs
A 1/27-2/4/15 FDA inspection at Emcure Pharmaceuticals, Maharashtra, India, found significant violations of current good manufacturing practices for finished pharmaceuticals. A 3/3 Warning Letter says that the violations included: failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of
Devices
At a 2/18 FDA/Industry MDUFA 4 reauthorization meeting, AdvaMed, MDMA (the Medical Device Manufacturers Association, and MITA (the Medical Imaging and Technology Alliance) presented an updated proposal package including continuation of MDUFA 3 base resources to maintain the MDUFA 3 FTE levels and maintain FDA’s current performance,
Drugs
Harvard Medical School professor Jerry Avorn raises objections to the loosening of First Amendment controls on what drug manufacturers are permitted to say about their products. Writing in a Health Affairs blog post, he says the “real issue is whether we as a society feel that there is something special
Drugs
FDA has accepted for priority review a Roche Group BLA for MPDL3280A (atezolizumab) for treating people with locally advanced or metastatic urothelial carcinoma who had disease progression during or after platinum-based chemotherapy in the metastatic setting. The company is also seeking approval for use in those whose disease worsened
Devices
Abbott Vascular has begun a Class 1 recall of its Vascular MitraClip Delivery System, which is intended to treat patients with degenerative mitral regurgitation. The company has received reports of cases where the clip delivery system could not be detached from the clip due to a device malfunction. An agency
Drugs
Xavier University and PricewaterhouseCoopers have identified 11 drug quality risk metrics linked to patient safety that could be viewed during an FDA inspection. According to a just-posted Pharmaceutical Quality Metrics White Paper, the metrics were developed by a team of 31 industry professionals as a tool that stakeholders across
Devices
An 8/4-8/13/15 and 10/6-11/4/15 FDA inspection at Innovative Sterilization Technologies, Dayton, OH, found Quality System Regulation violations in the firm’s work as the specification developer of the One Tray sealed sterilization container. A 3/2 Warning Letter from the agency’s
Drugs
Aralez Pharmaceuticals has resubmitted an NDA for Yosprala (aspirin and omeprazole), indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. “Secondary prevention with aspirin may be recommended in patients who have had a myocardial infarction or unstable angina pectoris, chronic stable angina
FDA Policy/General
Federal Register Notice: FDA is seeking comments on the final results of a study of the workload volume and full costs associated with the process for reviewing biosimilar biological product applications (final report). This study was conducted by an independent consulting firm, and it fulfills FDA’s statutory requirement under
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice,
FDA Policy/General
Federal Register Notice: FDA seeks comments on extending Office of Management and Budget approval on the existing recordkeeping requirements for this information collection on animal proteins prohibited in ruminant feed. Comments should be submitted b y 5/16. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document including Kenalog, Indocin, Bactrim and Bactrim Pediatric, and Nitropress were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. It provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 5/5, from 8 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.