Drugs
FDA has approved an AstraZeneca NDA for Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol, indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The product is not indicated for treating asthma or for relieving acute bronchospasm.
Drugs
Believing from media reports that FDA is nearing a decision on its proposal to amend regulations governing procedures for application holders of an approved drug or biologic product to make unilateral changes in the product labeling, Washington Legal Foundation has reiterated its objection to the proposal and its support for
Drugs
FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) tablets for treating patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Approval was based on data from the Phase 3 METEOR trial, which met
Drugs
FDA has granted Bristol-Myers Squibb a breakthrough therapy designation for Opdivo for treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. The designation is based on results from the CheckMate-141 study, a Phase 3, open-label, randomized trial evaluating Opdivo
Drugs
FDA has approved an AbbVie supplemental NDA for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer
Devices
FDA has cleared an Exactech 510(k) to market its Vantage Total Ankle to treat patients who suffer from arthritis in the ankle. The device is designed with a curved surface talar component that is engineered to fit the anatomy of the diseased talus and restore the joint line. It
Drugs
FDA has released a guidance on “Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products” that provides recommendations to help industry’s development and validation of immune assays for assessing the immunogenicity of therapeutic protein products during clinical trials. It includes input on developing and validating screening, confirmatory,
Drugs
Octapharma USA has recalled one lot (#K551A8441) of Octagam [immune globulin intravenous (human)] 5% liquid preparation due to an increased number of reports of hypersensitivity events. “Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA,
FDA Policy/General
Federal Register Notice: FDA has determined that Thalitone (chlorthalidone USP) tablets, 15 mg were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for chlorthalidone USP tablets, 15 mg, if all other legal and regulatory requirements are met. To view this
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has voted 7 to 6 that a Sarepta Therapeutics NDA did not provide substantial evidence from adequate and well controlled studies that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit in patients
FDA Policy/General
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. It provides recommendations to facilitate industry’s development and validation of immune assays for assessing the immunogenicity of therapeutic protein products during clinical trials. It
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for the document entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers” in the 3/4 Federal Register. FDA requested comments about the quality, safety, and continued effectiveness of medical
FDA Policy/General
BIOLOGICS CBER Workshop on Developing HCT/Ps Federal Register Notice: CBER announcing a public workshop 9/8 entitled “Scientific Evidence in Development of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Subject to Premarket Approval.” Its purpose is to identify and discuss scientific considerations and challenges to
FDA Policy/General
Federal Register Notice: FDA is seeking public comments on reporting requirements for firms that intend to export certain unapproved medical devices. Comments should be submitted by 6/21. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. The authorization was requested by OraSure Technologies and contains, among other things, conditions on the emergency use of
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus in response to the Zika virus outbreak in the Americas. It contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. To view this
FDA Policy/General
Federal Register Notice: CBER announcing a public workshop 9/8 entitled “Scientific Evidence in Development of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Subject to Premarket Approval.” Its purpose is to identify and discuss scientific considerations and challenges to help inform the development of HCT/Ps
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Nihon Nohyaku Co.’s Luzu is 2,242 days for extending a patent which claims the human drug product. Luzu is indicated for topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Tricophyton
FDA Policy/General
Federal Register Notice: FDA will hold a two-day public hearing 9/12-13 to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The draft guidances are: Same Surgical Procedure Exception under 21 CFR 1271.
Devices
Rep. Jim Langevin (D-RI), who co-chairs the Congressional Cybersecurity Caucus, is supporting FDA’s draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.” In a 4/21 letter to the agency, Langevin said the guidance, when finalized, should help improve medical device cybersecurity. “The risk-based nature
Drugs
FDA has removed from its import alert NeuroDerm’s third-party manufacturer of infusion pumps used to deliver the investigational drug ND0612 in its current clinical trials. The alert was ordered on Can SpA’s devices 7/2015 after FDA sent it a Warning Letter requesting additional documentation pertaining to
Devices
In a rare move, FDA has proposed a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that can’t be addressed in product labeling. ESDs send electrical shocks through electrodes attached to the skin