FDA Policy/General
Federal Register notice: FDA has classified the temporary catheter for embolic protection during transcatheter intracardiac procedures into Class 2 (special controls). The action is in response to a 9/2016 de novo classification request by Claret Medical for its Sentinel Cerebral Protection System. The agency has identified the generic type
Drugs
The Biosimilars Council, a division of the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association), says a Pennsylvania federal court should not grant a motion by Johnson & Johnson and its Janssen Biotech subsidiary to dismiss a suit brought by Pfizer over its biosimilar Inflectra (infliximab), which is trying
Devices
The Pew Charitable Trusts says HHS should support incorporation of medical device identifiers, particularly implants such as cardiac stents and artificial joints, to claims data as part of efforts to promote healthcare system competition and efficiency. The group’s 1/25 letter says that adding unique device identifiers (UDIs) to
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Daito Kasei Kogyo Co. Okayama, Japan (1/18): FDA inspected the firm 7/2017 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm failed
Devices
FDA has cleared a Multi Radiance Medical 510(k) for the MR4 Laser technology for neck and shoulder pain relief. The clearance was based on data from a randomized, double blind, controlled study demonstrating that the device is more effective than placebo for reducing neck and shoulder pain, according to
Drugs
FDA has approved a CutisPharma NDA for Firvanq (vancomycin hydrochloride) oral solution for treating Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. The company says that Firvanq will replace its FIRST-Vancomycin Unit-of-Use Compounding Kit, which has been available to pharmacists that
Drugs
FDA has released a draft guidance on “Qualified Infectious Disease Product Designation Questions and Answers.” The document provides information on implementing the FDA Safety and Innovation Act’s section on “Generating Antibiotic Incentives Now (GAIN),” which creates incentives for developing antibacterial and antifungal drug products that treat serious or life-
Drugs
FDA and Duke University’s Center for Health Policy have announced a 4/16 public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will help the agency develop a guidance on the subject. It will include discussion about various ways in which participation in clinical trials
Drugs
FDA has accepted for review a Theravance Biopharma and Mylan NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist for treating chronic obstructive pulmonary disease (COPD). The agency has set a user fee review action target date of 11/13, and it has told the companies that an
FDA Policy/General
Federal Register notice: FDA is providing interested parties with the opportunity to submit written comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the
Drugs
FDA has updated a guidance for Institutional Review Boards and Clinical Investigators to revise its “Payment for Research Subjects: Information Sheet” to clarify that reimbursement for travel expenses to clinical trial sites and associated costs (airfare, parking, and lodging) are acceptable under current practices. The updates were made based on
Devices
FDA has cleared an electroCore 510(k) for an expanded label for gammaCore as an acute treatment of pain associated with migraine in adult patients. The neuromodulation treatment is delivered by a hand-held unit that stimulates the vagus nerve through the skin. It was initially cleared 4/2017 for
Drugs
FDA has issued Aradigm a complete response letter (CRL) on its NDA for Linhaliq (liposomal ciprofloxacin for inhalation) as a treatment for non-cystic fibrosis bronchiectasis patients with chronic Pseudomonas aeruginosa (P. aeruginosa) lung infections. The letter says the NDA cannot be approved in its present form, and provides recommendations
FDA Policy/General
Sanofi has agreed to buy Belgium-based Ablynx for $4.8 billion. Ablynx focuses on Nanobodies, a novel class of next-generation biologics. The company has a pipeline of more than 45 proprietary and partnered drug candidates for treating hematology, inflammation, immuno-oncology and respiratory diseases. Casi Pharma has acquired
FDA Policy/General
Regulatory Review Period Determined for Vraylar Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. 01/26/2018 Regulatory Review Period Determined for Varubi Federal Register notice: FDA determines for patent extension purposes the regulatory review
Devices
CDRH has posted review metrics for its Accredited Persons Program for 510(k)s. The metrics are mandated by the device user fee program. According to the report, 18 third-party 510(k)s have been reviewed. The average total time from receipt of a 510(k) to a final
Drugs
FDA has approved an Advanced Accelerator Applications NDA for Lutathera (lutetium Lu 177 dotatate) for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency says this is the first radiopharmaceutical approved for treating the tumors. The drug works by binding to a part of a cell called a somatostatin receptor, which
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. Of this time, 2,709 days occurred during the testing phase and 1,033 days occurred during the approval phase. Vraylar is indicated for treating schizophrenia
Drugs
FDA has tentatively approved a Perrigo ANDA for a generic version of Valeant Pharmaceutical’s Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%), indicated for topical treatment of acne vulgaris in patients 12 years of age and older. Branded market sales for the last 12 months were
Drugs
The Washington DC District Court has remanded to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the company’s Sensipar (cinacalcet hydrochloride). In its complaint, Amgen argued that FDA’s decision to grant an earlier pediatric exclusivity award to Johnson & Johnson’s
FDA Policy/General
FDA commissioner Scott Gottlieb has ordered the termination of an agency-sponsored animal (monkey) study of nicotine exposure over inhumane treatment concerns. Four monkeys died and now the remaining animals have been placed in a permanent sanctuary home. Gottlieb said that an internal review team “will determine the safety and
Devices
FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,” the