Devices
FDA has approved a Biotronik PMA for its Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. The device also has a remote monitoring feature with daily automatic transmission, and a closed-loop stimulation feature that adapts the
Devices
A 9/14-25/15 FDA inspection at Grams Medical Products, Costa Mesa, CA, found Quality System Regulation violations in the firm’s manufacturing of the Grams Aspirator S-300. A just-released 3/17 Warning Letter from the agency’s Los Angeles District Office says that violations listed on
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Apotheca Supply, Inc. dba Apothecares Decatur, AL (4/7). Inspected 2/10-12/15. CGMP deviations, adulterated: The firm’s quality unit failed to review and approve all quality
Drugs
Responding to a Depomed 1/29 citizen petition, FDA says that it must deny the petition at this time because it cannot interpret contradictory information on a patent use code for the company’s Nucynta ER (tapentadol). The petition asked the agency to stay final approval of any ANDA referencing
Drugs
FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with using the antipsychotic drug aripiprazole (Otsuka’s Abilify and Abilify Maintena, Alkermes’ Aristada, and generics). An agency drug safety communication says that the uncontrollable urges were reported to have stopped
Devices
FDA has cleared a First Ray 510(k) for its Stealth Staple System, an intraosseous small bone fixation device for treating arthrodesis, osteotomies and bone fractures. Current standard-of-care devices are primarily bone plates and bone screws, or bone staples, according to the company. “Due to the prominence above
Devices
AdvaMed says there are several items in an FDA draft guidance on homologous use of human cells, tissue, and cellular and tissue-based products (HCT/Ps) that industry views positively, and several areas where industry disagrees or believes that improvements are needed. In a 4/20 comment letter, it says
Drugs
A 2/10-12/15 FDA inspection at Apotheca Supply, a Decatur, AL, pharmaceutical manufacturing (repackaging and relabeling) facility found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients, according to a just-released Warning Letter from the agency’s New Orleans District Office. Specific
Drugs
FDA has posted a draft guidance on “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral (DAA) Drugs for Treatment” that offers recommendations on the overall development program and clinical trial designs to support such drugs. The document is intended to serve as a focus for continued discussions among the
Devices
Attorney Michelle Yorty (Dechert) is praising a Texas federal court decision that threw out with prejudice all claims against Covidien from a patient who claimed that the company’s embolization device that was implanted in her brain caused her to suffer a blocked blood vessel that led to mini strokes
Drugs
FDA has released a draft guidance on “Special Protocol Assessment (SPA)” that provides procedures and general policies adopted by CDER/CBER for such an assessment. The process allows a sponsor to request a meeting with the agency to reach agreement on the design and size of certain clinical trials, clinical
Devices
Despite reported issuance of a Justice Department subpoena against the company, FDA 5/2 ducked when asked if it is investigating allegedly defective Halyard Health surgical gowns reported 5/1 by CBS 60 Minutes. Agency spokesperson Angela Stark trotted out FDA’s routine evasion in an email to FDA Webview:
Drugs
FDA has approved an Eisai NDA for Fycompa (perampanel) oral suspension as adjunctive therapy for treating partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative
Devices
FDA has cleared a Medtronic 510(k) for its StrataMR valves and shunts, which are used in treating patients with hydrocephalus and cerebrospinal fluid disorders. The clearance covers the device’s acceptable performance during magnetic resonance imaging (MRI) examinations, according to the company. The device contains a magnet inside the
Drugs
FDA has recently begun issuing many more “Easily Correctable Deficiency (ECD)” and “Information Request (IR)” letters to generic drug makers over ANDAs that have been submitted to CDER, according to a new generic drug dashboard report. The agency says this is a positive move because the increase in these categories
Drugs
FDA has approved a brand name change for H. Lundbeck’s antidepressant Brintellix (vortioxetine) to help decrease prescribing and dispensing errors resulting from name confusion with AstraZeneca’s anti-blood clotting medication Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be
Devices
In a 4/29 Washington Legal Foundations Legal Backgrounder, attorneys from King & Spalding examine the recent U.S. v Vascular Solutions acquittal and analyze the government’s shift in strategy as the courts come to terms on the importance of First Amendment protections with regar its regulatory and enforcement
Drugs
Novo Nordisk says it will file in the fourth quarter an NDA for its diabetes drug semaglutide based on positive data from its sixth and last global Phase 3a trial, SUSTAIN6. The new glucagon-like peptide-1 (GLP-1) analog, which is intended to be administered subcutaneously once weekly, achieved
Drugs
FDA has approved an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. “Hallucinations or delusions can occur in as many as 50% of patients with Parkinson’s disease at some time
FDA Policy/General
Regen BioPharma has entered into a non-exclusive license agreement with Pan Am Cancer Treatment Center in Tijuana, Mexico to test HemaXellerate in a first-in-human proof of concept study. According to the company, HemaXellerate is comprised of cells extracted from the patient’s own fat tissue and processed
FDA Policy/General
BIOLOGICS CBER Releases eSubmitter Program for Vaccine AERS Federal Register Notice: CBER is making available a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. It is a free software
FDA Policy/General
FDA is developing a new genomics project called Sequencing Quality Control Phase 2 (SEQC2) that aims to develop quality control metrics and benchmark bioinformatics approaches for analyzing whole genome sequencing and targeted gene sequencing data. The project is also designed to achieve best practices, to develop standard analysis protocols, and