Devices
Commenting on an FDA draft guidance on categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions, AdvaMed says it supports CMS coverage of all IDE trials. The comment letter says that in recent years CMS declined to cover only
Devices
FDA has published a guidance, Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, to make recommendations to establishments that make donor eligibility determinations on using FDA-licensed nucleic acid tests (NAT)
Drugs
Attorney Lindsay Breedlove (Pepper Hamilton) says that a Massachusetts federal court rejected efforts by a union to certify a class action against Forest Laboratories under the Racketeer Influenced and Corrupt Organization Act (RICO). In a Washington Legal Foundation Legal Opinion Letter, Breedlove writes that although the court found that the
Biologics
A Massachusetts federal court has issued summary judgment in favor of Celltrion Healthcare and Hospira involving patent infringement lawsuits related to their biosimilar product referencing Janssen Biotech’s Remicade (infliximab). The court found that a Janssen patent is invalid. FDA approved the product in April (see story), and the product
Devices
FDA is recommending that health care facilities stop using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for reprocessing duodenoscopes because of inadequate reprocessing validation and performance data. An agency safety notice says the reprocessors remain available to reprocess other flexible endoscopes. FDA says it continues to work closely
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “FDA’s Voluntary Qualified Importer Program; Guidance for Industry,” 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, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Regulatory Classification of Pharmaceutical Co-Crystals. It provides applicants planning to submit NDAs and ANDAs with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products. It provides establishments that make donor eligibility determinations for donors of
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Pediatric Advisory Committee 9/14, from 8 a.m. to 5:30 p.m. at DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 Wisconsin Ave., Bethesda, MD. The panel will discuss pediatric-focused safety reviews, as mandated by the Best
FDA Policy/General
Federal Register Final rule: FDA is issuing a final rule that amends and clarifies the criteria in its regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act because the
Drugs
User fees collected by FDA from drug manufacturers to fund drug reviews total $7.67 billion since 1992, according to an Avalere Health analysis. The company looked at the three types of prescription drug user fees — product fees paid for each product being sold on the market, establishment fees paid
Drugs
FDA has given the green light for Female Health Co. and Aspen Park Pharmaceuticals to file a 505(b)(2) NDA for tamsulosin DRS (Delayed Release Sachet), indicated for treating benign prostatic hyperplasia. “Our product is a novel powder which utilizes a proprietary extended release formulation of the existing active
Drugs
A 6/15-6/18 FDA inspection at Zhejiang Medicine Co., Xinchang Pharmaceutical Factory, Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients, according to an 8/4 Warning Letter. Specific deviations included: * failing to have laboratory control records that include complete data
Devices
An 11/9/15-11/11/15 FDA inspection at Helica Instruments, Edinburgh, United Kingdom, found multiple Quality System Regulation violations in the firm’s production of an electrosurgical cutting and coagulation device and accessories, including the Helica Thermal Coagulator. A just-released 5/13 Warning Letter says that violations
Drugs
The Supreme Court has been asked to review a Federal Circuit Appeals Court ruling that a statutory safe harbor does not apply to a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Attorneys Amy Hayden and Ewa Davison (Fenwick & West) write in
FDA Policy/General
FDA’s Center for Veterinary Medicine has approved Leawood, KS-based Arata Therapeutics’ Nocita (bupivacaine liposome injectable suspension) to provides post-operative pain relief for knee surgery in dogs. According to an 8/16 agency news release, the drug is a liposome formulation of bupivacaine, an amide local anesthetic that
Drugs
A 6/22-7/10 FDA inspection at Noven Pharmaceuticals, Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/5 Warning Letter from the agency’s Florida District Office. Specific violations included: * failing to establish and document the accuracy, sensitivity,
Drugs
FDA says it has placed an Import Alert on all products produced by Laxachem Organics, Maharashtra, India, due to its refusal to allow FDA investigators to inspect its facility. The alert stops all of the company’s products from entering the U.S., according to an agency statement. FDA says
Drugs
The FDA Group says that to prevent potentially damaging consequences when things go wrong, manufacturers need to take on effective remediation projects that not only identify the root causes of particular problems, but put comprehensive plans in place to remedy them and communicate the improvements to FDA effectively. In a
Drugs
AstraZeneca says that a draft FDA guidance on quality attribute considerations for chewable tablets does not have any text related to tablet hardness or chewing difficulty on stability. “Tablets may harden over time or can turn into a moist gritty mass as superdisintegrants can pick up moisture and soften the
Drugs
FDA believes proposed recommendations for reauthorizing the Prescription Drug User Fee Act (PDUFA) for fiscal years 2018 through 2022 will provide strong and a comprehensive set of enhancements and refinements to the user fee program. Speaking at a 8/15 user fee pubic meeting, CDER director Janet Woodcock said she
Drugs
CDER has posted a draft guidance on “Regulatory Classification of Pharmaceutical Co-Crystals” that provides sponsors with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. The document also provides information about the data that applicants should submit to support the appropriate classification of a co-