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
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues” that describes the agency’s current recommendations regarding the overall development program and clinical trial designs for such products. To view the notice, click here.
Drugs
Researchers from several academic medical centers say that while the number of reports of pregnancies, abortions, and fetal defects among women taking isotretinoin has decreased since peaking around the 2006 start of the iPLEDGE program, persistent reporting of pregnancy-related events in the last decade warrants investigation into the efficacy
Devices
Pear Therapeutics is asking FDA for marketing authorization for its Somryst, described as a prescription digital therapeutic intended for use in treating adults with chronic insomnia and depression. The company says Somryst is intended to provide neurobehavioral interventions, specifically cognitive behavioral therapy for insomnia and sleep restriction driven by algorithms
Drugs
Through a risk-based quality management system, FDA can receive data that are reliable, interpretable, and traceable, and thus may be able to act on a drug application before the user fee deadline. And acting on an application sooner can result in less expense for the sponsor. That’s the
Drugs
FDA has accepted Allergan’s NDA for Bimatoprost sustained-release for use in patients with open-angle glaucoma or ocular hypertension. The company says that if Bimatoprost SR is approved, it would be the first-in-class sustained-release, biodegradable implant for reducing intraocular pressure in patients with open-angle
Drugs
The CDER Office of Generic Drugs (OGD) FY 2018 GDUFA Science and Research Report shows that during FY 2018, the first year of GDUFA 2, the OGD Office of Research and Standards awarded 13 new research contracts and 11 grants for innovative research projects on generics. The report says that
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The guidance describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. To view the notice,
Drugs
Novartis says it has reserved about $700 million to settle U.S. government allegations that it illegally enticed physicians to prescribe its drugs. A whistleblower lawsuit has accused the company of paying thousands of doctors with speaking fees, fishing trips and outings at Hooters restaurants to boost sales of hypertension
Drugs
FDA has accepted for review a Horizon Therapeutics NDA for Procysbi (cysteamine bitartrate) delayed-release oral granules in packets, a new dosage form intended to provide another option for patients. Currently, Procysbi is approved in a delayed-release capsule form for treating patients with nephropathic cystinosis. If approved, the oral