Drugs
FDA says it is continuing to review relevant data about an allegedly faulty device that was used in a clinical trial supporting approval of Bayer’s Xarelto (rivaroxaban). The blood thinner, marketed in the U.S. by Johnson & Johnson’s Janssen unit, is indicated to prevent ischemic stroke in
Drugs
FDA has sent PTC Therapeutics a Refuse to File letter on the company’s NDA for Translarna (ataluren), an oral, first-in-class, protein restoration therapy for treating nonsense mutation Duchenne muscular dystrophy (DMD). The agency’s letter said the NDA was not sufficiently complete to permit a substantive review,
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products will hold a public workshop 3/17-18 to gather scientific information on waterpipes and waterpipe tobacco and to identify areas of research that may inform the Center’s regulation of these tobacco products. FDA is also opening a public docket
Drugs
A 11/17-11/21/14 FDA inspection at OPS International, doing business as Olympia Pharmacy, Orlando, FL, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” A 2/4 Warning Letter from the agency’s Florida District Office says the firm’s
Drugs
Unger Consulting principal Barbara Unger says that there has been a CDER enforcement focus on compounding pharmacies between FY 2013 and FY 2015, at the possible expense of other U.S. and outside-U.S. pharma sites. She also finds that inspection observations did not change significantly between FY 2013
Drugs
Clinical investigations overseen by Gregory Tracey, Hoboken, NJ, did not follow the investigational plan and enrolled ineligible subjects, according to a 12/16/15 Warning Letter from FDA. The letter was a result of a 3/25-4/15/15 inspection as part of the agency’s Bioresearch Monitoring Program.
Drugs
FDA has accepted for review a Medivation and Astellas Pharma supplemental NDA for Xtandi (enzalutamide) capsules, indicated for treating metastatic castration-resistant prostate cancer (mCRPC). The submission includes findings from the Phase 2 TERRAIN and STRIVE studies, and seeks to update the relevant clinical sections within the current indication. The
FDA Policy/General
Federal Register Notice: FDA is extending the comment period provided in the 1/26 notice entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. Comments on the guidance should be submitted by 4/28. To view
Devices
FDA medical device reviewers say there are safety issues raised by the Astora Women’s Health TOPAS treatment for fecal incontinence to be considered by the Gastroenterology and Urology Devices Panel at its 2/25 meeting. A briefing document released in advance of the meeting says the device is a
FDA Policy/General
FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Infusion Systems of SW Florida Inc., dba Myerlee Pharmacy Fort Myers, FL (2/3). Inspected 12/1-22/14. GMP violations, adulterated: The firm was not receiving valid prescriptions for
Drugs
There were 1,017 CDER inspections overseen by the Office of Scientific Investigations and Office of Study Integrity and Surveillance in 2015, down from the 1,041 inspections in 2014. OF the total, 430 were clinical investigator inspections, 319 dealt with bioequivalence, 92 involved postmarketing adverse drug experience, and 84
Devices
FDA has approved Boston Scientific’s Acuity X4 Quadripolar Left Ventricular (LV) leads. “The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the
Drugs
Baltimore City Health Department and Rhode Island Department of Health have begun a petition at change.org urging FDA to require black box warnings on opioids and benzodiazepines to warn about overdose risks when used concurrently. The health departments say the products require clear warnings to educate healthcare providers and
Drugs
FDA has granted Trevena a breakthrough therapy designation for intravenous TRV130 (oliceridine) for managing moderate-to-severe acute pain. The drug was designed to “optimize opioid receptor pharmacology to deliver an improved analgesic profile,” the company says. It is the “first receptor G protein pathway selective modulator (GPS) – a biased
Drugs
FDA has accepted for review a Sanofi NDA for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for treating of adults with Type 2 diabetes. The submission contained a “Priority Review Voucher” that will expedite the review, with an action
Drugs
FDA has removed a clinical hold against Aeolus Pharmaceuticals’ AEOL 10150, allowing the company to move forward with a Phase 1 safety study in healthy normal volunteers in the second quarter. The agency placed the hold in 2014, asking for more information on the product’s toxicology data that supported
FDA Policy/General
Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee will meet 4/15, from 8 a.m. to 5 p.m. at the Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss data submitted by Galderma Laboratories to support a supplemental NDA for
FDA Policy/General
The Senate 2/22 succeeded (80 to 6) in a cloture vote to advance Robert Califf’s nomination to be the next FDA commissioner. A full Senate floor vote on the nomination could take place as early as 2/23. Opposition to advancing the nomination was led by Sens. Joe
Drugs
FDA has denied an Amedra Pharmaceuticals petition asking the agency not to approve any ANDA referencing Albenza (albendazole) unless it meets specific criteria listed in the petition. The petition objected to a draft guidance that instructed ANDA applicants to measure both albendazole and its active metabolite, albendazole sulfoxide and recommended
Drugs
The Senate Committee on Homeland Security and Governmental Affairs has asked FDA to explain why it has not finalized a 2/2015 draft guidance to streamline drug expanded-access requests to allow patients access to investigational therapies outside of a clinical trial. In a 2/18 letter to the agency,
Devices
FDA’s Orthopedic and Rehabilitation Devices Panel has voted 7 to 4 not to recommend approval of a Medtronic PMA for the DIAM Spinal Stabilization System for use in skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than one
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection associated with the guidance Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. Comments should be submitted by 4/