FDA Policy/General
FDA announced 3/29 the first simultaneous review and approval of a new drug for food-producing animals by the agency's Center for Veterinary Medicine (CVM) and Health Canada. The drug, Eli Lilly Elanco Animal Health's Imrestor (pegbovigrastim injection), is intended to reduce the incidence of
FDA Policy/General
Today FDA posted its latest batch of Warning Letter. They can be accessed by clicking on the link following each letter. Leiter’s Compounding San Jose, CA (2/29). Inspected 9/15/14-10/7/14. CGMP deviations, adulterated: The facility failed to submit a report to FDA upon initial
Drugs
Alder BioPharmaceuticals has reported what it calls “positive top-line” data from two clinical trials evaluating ALD403, a monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide. Data from a Phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine
Drugs
Reliable Drug Pharmacy has recalled all unexpired lots of compounded products due to concerns about quality assurance and potential mislabelings. Most recalled products were distributed to patients and veterinarians within California, and a few products were shipped to Hawaii, New Mexico, and Michigan, a recall notice says. The recall was
Drugs
FDA has denied an Eagle Pharmaceuticals request for seven years orphan drug exclusivity for Bendeka (bendamustine HCI), a liquid, low-volume (50 mL) 10-minute infusion for treating chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment
FDA Policy/General
Federal Register Notice: CDER and the Critical Path Institute will co-sponsor a public scientific workshop 4/25 from 8:30 a.m. to 5 p.m. Its purpose is to discuss the following issues: Application of toxicometrics as a translational safety strategy that integrates nonclinical and clinical safety approaches;
Drugs
Dr. Reddy’s Laboratories and XenoPort have entered into a license agreement that grants Dr. Reddy’s exclusive U.S. rights for developing and commercializing XenoPort’s clinical-stage oral new chemical entity XP23829 for treating moderate-to-severe chronic plaque psoriasis. The therapy is also being considered for treating
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for diagnosis of Zika virus infection in response to the Zika virus outbreak in the Americas. The authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device.
FDA Policy/General
Federal Register Final rule: FDA is amending its regulations to update the address for applicants to submit investigational new drug applications for biological products regulated by CDER. FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems to correct a typographical error.
Devices
FDA has updated a 10/2015 safety communication calling attention to infections associated with heater-cooler devices and steps that healthcare providers and facilities can take to mitigate patient risk. Over the past few months, the agency says it has continued to evaluate contamination and infection-related issues associated with
Drugs
FDA accepted for review an Aralez Pharmaceuticals NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. “Secondary prevention with aspirin may be recommended in patients who have had a myocardial infarction or unstable angina pectoris,
FDA Policy/General
The House Committee on Science, Space and Technology has opened an investigation into the dismissal of a researcher working under a fellowship at CBER, particularly allegations that the fellow was terminated in retaliation for his 2014 testimony before Congress during the Ebola crisis that may have cast the agency in
FDA Policy/General
DEVICES FDA Adds Device Patient Engagement Advisory Committee Federal Register Final rule: FDA is amending the standing advisory committees’ regulations to add the Patient Engagement Advisory Committee. Its function is to provide advice to the commissioner on complex issues relating to medical devices, the regulation of devices, and their use
Devices
TransEnterix says FDA has extended its review of a 510(k) for the SurgiBot System, a robotic surgery device for use in laparoscopic procedures. The system allows multiple instruments to be introduced and deployed through a single incision. The device’s flexible instruments may be controlled directly by the surgeon
Drugs
A jury has ordered Gilead Sciences to pay Merck $200 million in damages for infringing two Merck patents related to Gilead’s blockbuster Sovaldi and Harvoni hepatitis C drugs. Merck reportedly is also seeking a 10% royalty on Gilead’s sales going forward. That aspect will be argued in a
Drugs
Accurexa and University of California, San Francisco have received a written response from FDA providing guidance on non-clinical activities that are necessary to enable the filing of a future IND for a combined stem cell/gene transfer therapeutic (CNS10-NPC GDNF) for treating Parkinson’s Disease using Accurexa'
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. It recommends studies, including comparative in vitro studies, that should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less
Drugs
FDA has denied a 2015 Teva petition asking it not to approve any ANDAs that reference Treanda (bendamustine hydrochloride) until its orphan exclusivity for indolent B-cell non-Hodgkin’s lymphoma (iNHL) has expired. FDA approved Treanda in 3/2008 for treating chronic lymphocytic leukemia (CLL). The orphan exclusivity for
Drugs
FDA reviewers say an Acadia Pharmaceuticals pivotal study, which supports an NDA for Nuplazid (pimavanserin) and its use in treating psychosis associated with Parkinson’s Disease (PDP), “established statistical evidence” and does not worsen Parkinson’s Disease status. In a briefing document released in advance of a 3/29 Psychopharmacologic
Drugs
FDA has issued a draft guidance, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, to assist potential applicants to develop and submit an ANDA for a generic version of a solid oral opioid drug product that has the potential for abuse and which references
Devices
Rep. Mike Fitzpatrick (R-PA) is asking members of congressional appropriations subcommittees to exclude the Bayer Essure permanent sterilization device from federal procurement. He says that the government has spent millions of dollars on the device in the past few years. Letters were sent to the subcommittees on military construction,
Drugs
FDA is seeking comment by 5/3 on its February draft guidance on human factor studies and related clinical study considerations in combination product design and development. Writing in an FDA Voice blog post, associate commissioner for special medical programs Jill Warner and Office of Combination Products director Thinh Nguyen