Biologics
FDA has approved a Pfizer BLA for Ruxience (rituximab-pvvr), a biosimilar to Biogen’s Rituxan for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. Approval was based on the review of a comprehensive data package, which demonstrated
Drugs
FDA has approved nine ANDAs for first generics of Pfizer’s Lyrica (pregabalin) for managing neuropathic pain associated with diabetic peripheral neuropathy, and for managing postherpetic neuralgia. The generics are also indicated as adjunctive therapy for treating partial onset seizures in patients 17 years of age and older, for managing
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection for “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.” The collection is intended to allow FDA to use quick turnaround surveys, focus groups, and in-depth interviews collected from consumers and other stakeholders to communicate FDA issues
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Experimental Study of an Accelerated Approval Disclosure * Interstate Shellfish Dealer’s Certificate * Administrative Detention and Banned Medical Devices * Medical Device User Fee Small Business Qualifications and Certifications * Individual Patient Expanded Access
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Bar Code Label Requirement for Human Drug and Biological Products” (OMB Control Number 0910-0537). The agency requires bar codes on most human prescription drug products and on over-the-counter drug products that are dispensed under
Drugs
FDA has issued Biohaven Pharmaceutical Holding Co. a complete response letter on a 505(b)2 application seeking approval for Nurtec (riluzole) for treating amyotrophic lateral sclerosis (ALS). The letter raised concerns with the use of an active pharmaceutical ingredient (API) that was manufactured by Apotex Pharmachem India Private Ltd.
Devices
Becton Dickinson has recalled its Alaris Pump Module Model 8100 bezel assembly because of a defect that could result in free flow, over-infusion, under-infusion, or interruption of infusion. A recall notice says that the bezel posts may become cracked and separated which could lead to inaccurate fluid delivery
Drugs
Vanda Pharmaceuticals says it has received FDA notification about undisclosed deficiencies that “preclude discussion of labeling and postmarketing requirements/commitments” involving a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. FDA stated that the notification does not reflect a final decision on the information under review. The user
Drugs
A new study in BMJ criticizes the strength of the data on which FDA based its 2017 approval of an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. Study researchers
FDA Policy/General
FDA has released a final guidance on “Postmarketing Safety Reporting for Combination Products.” The document addresses how to comply with a 2016 final rule on postmarketing safety reporting (PMSR) requirements for combination products. “Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations
FDA Policy/General
Merck Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals have entered into a collaboration agreement to evaluate avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells in patients with heavily pre-treated, recurrent ovarian
FDA Policy/General
DEVICES FDA has approved an Advance Circulatory Systems PMA for the ResQCPR System, a two-device system for first responders to use while performing cardiopulmonary resuscitation (CPR) on people in cardiac arrest. The first device, the ResQPump Active Compression Decompression CPR Device, has a double-grip handle that when attached
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria,” (OMB Control Number 0910-0510). The guidance provides information for those
FDA Policy/General
Federal Register notice: FDA has announced that it will adopt the current version of the Geopolitical Entities, Names, and Codes (GENC) Standard on 12/17/2020. The standard specifies an authoritative set of country codes and names for use by the U.S. Government for information exchange, using ISO 3166
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct research to determine how physician perceptions are influenced by drug marketing, specifically with variations in information context (presence of graphical elements and information delivery vehicle— medical journal abstract or sales aid), methodologic rigor of the underlying clinical study
Drugs
FDA has approved a Celgene NDA for Otezla (apremilast) 30 mg twice daily for treating adult patients with oral ulcers associated with Behcet’s Disease. The oral, selective inhibitor of phosphodiesterase 4 was approved based on efficacy and safety results from the Phase 3 RELIEF study evaluating the drug in
Drugs
FDA has released a final guidance on “Submitting Next Generation Sequencing Data to the Division of Antiviral Products —Technical Specifications Document.” The document provides FDA’s current thinking on submitting next generation nucleotide sequence analysis procedures and data in support of resistance assessments for developing antiviral drug products. “The Division
Devices
FDA has cleared an Erchonia 510(k) to market FX low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain. Clearance was based on data from placebo-controlled clinical trials with 255 patients, which showed that those treated with the laser documented a 49% average pain reduction post
Drugs
FDA has announced a 10/31 public meeting on “ICH Global Meeting on E8 Guideline on General Considerations for Clinical Trials.” The meeting is intended to discuss a planned revision to the E8 Guideline to provide updated guidance to address the increasing diversity of clinical trial designs and data sources
Devices
Becton Dickinson has recalled its Alaris Infusion Sets due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a “running status.” A recall notice says that a silicone segment of the affected device has non-
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension on the “Guidance: Emergency Use Authorization of Medical Products and Related Authorities,” (OMB Control Number 0910-0595). The guidance describes the data to support issuance of an emergency use authorization. To view the notice, click here.
Drugs
Amarin Pharma says it will respond within weeks to a citizen petition asking FDA to make an exception to the statutory requirements for synthetic omega-3. Amarin says its response will explain that a product with synthetic eicosapentaenoic acid cannot be legally marketed as a dietary supplement because such marketing