Drugs
NDA Group says its fourth annual comparison of drug approvals in the U.S. and Europe shows a drop in U.S. approvals, but not in the European Union. For 2016, the report says, there were 74 new drug approvals granted in the U.S. and EU. Of those new
Drugs
A 3/14-3/22/16 FDA inspection at Opto-Pharm, Singapore, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/16 Warning Letter. Specific violations observed during the inspection included * failing to establish and follow appropriate written procedures designed to prevent
Drugs
Perrigo says the flexibility provided by FDA in a revised quality metrics draft guidance to allow reporting by site or by product “has the potential to create added confusion for key partners across the supply chain due to the potential for some partners to prefer site reporting and others to
Drugs
An FDA inspection at the Northwestern University School of Medicine between 6/17/16 and 7/11/16 found that Division of Immunotherapy chief Richard Burt violated regulations governing the proper conduct of clinical studies involving investigational new drugs. Specific violations included: * failing to fulfill the general responsibilities of sponsors
Devices
House Energy and Commerce Committee lawmakers from both sides of the aisle urged Congress and the Trump Administration 3/28 to reauthorize medical device user fees for another five years before the program expires 9/30. During a hearing, CDRH director Jeff Shuren painted a rosy picture of an improving
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. DSE Healthcare Solutions Edison, New Jersey (3/16): FDA inspected the firm 8/2016 and documented significant GMP violations related to dietary supplements. The agency also cited the firm
FDA Policy/General
Federal Register notice: FDA has requested public comments on a new information collection related to a proposed “Experimental Study on Warning Statements for Cigarette Graphic Health Warnings” that would be conducted to support the graphic label statement provision of the Family Smoking Prevention and Tobacco Control Act. The online study
Drugs
The 3rd Circuit Court of Appeals has vacated a New Jersey federal court decision that failure-to-warn and other claims against Merck involving thigh bone fractures caused by its Fosamax (alendronate sodium) were preempted by federal law. The appeals court remanded the case to the lower court for further
Drugs
FDA has denied an Osmotica Pharmaceutical petition asking the agency to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets 225 mg and referencing the company’s NDA-approved product demonstrate in vivo bioequivalence using the 225 mg strength. A 12/9/2016 citizen petition said the
Drugs
As Congress and president Trump pledge to address skyrocketing drug costs, a new report by consumer advocacy group Public Citizen calls into question industry arguments that pricing reflects the high cost of research and development to bring new therapies to market. The 20 largest pharmaceutical corporations “collectively profited more than
FDA Policy/General
A new report by Pew Charitable Trusts says that currently available data on antibiotic use in the U.S. are insufficient. “Key stakeholders from the public, private, and nonprofit sectors must work together to improve the quality and availability of data in order to expand antibiotic stewardship in human health
FDA Policy/General
Senate Health, Education, Labor & Pension committee chair Lamar Alexander (R-TN) says a confirmation hearing will be scheduled soon after the committee receives Office of Government Ethics paperwork on Scott Gottlieb’s nomination to head FDA. The former FDA deputy commissioner under George W. Bush was nominated earlier this
Devices
FDA has approved an iCAD PMA for its PowerLook Tomo Detection device, a concurrent-read computer aided detection product for digital breast 3D tomosynthesis. “PowerLook Tomo Detection improves radiologists’ efficiency by automatically analyzing each tomosynthesis plane and identifying suspicious areas,” the company says. “The suspicious areas are naturally blended onto
Drugs
FDA has denied a 10/2016 Sandoz citizen petition that asked FDA not to approve generic copies of GlaxoSmithKline’s asthma inhaler Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) unless ANDA submissions contain data from a pharmacokinetic (PK) bioequivalence study that is stricter
FDA Policy/General
[Analysis by Jim Dickinson] Before there were user fees at FDA, the very idea was vigorously opposed inside and outside the agency for diverse reasons that mostly added up to the same fear: They would cause the effective collapse of the agency’s mission. Now, after almost a quarter-century
Drugs
FDA has approved a Tesaro, Inc. NDA for Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk in response to platinum-based chemotherapy. Zejula is a poly ADP-
Drugs
An Eagle Pharmaceuticals 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke (EHS) has been accepted for priority review. The agency has set a user fee review target date of 7/23. “Our innovative formulation of dantrolene sodium has unique properties that may allow Eagle’s
Drugs
Allergan says it will file an NDA in the second half of this year after announcing data from two Phase 3 trials of sarecycline for treating moderate to severe acne met their 12 week primary efficacy endpoints. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-
FDA Policy/General
Draft Guide on Kidney Transplantation Drugs 03/24/2017 Federal Register notice: FDA announces the availability of a draft guidance on “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention. CDRH Seeks Experiential Learning Program Players 03/23/2017 Federal Register notice: CDRH announces its 2017 Experiential Learning Program,
Devices
Phillips Healthcare has recalled its HeartStart MRx Monitor/Defibrillator due to battery and electrical issues. The device is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to those with sudden cardiac arrest. An FDA recall notice says that the battery and electrical connection
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance on “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention,” which addresses the agency’s current thinking on the overall development program and clinical trial designs for systemic drugs administered to kidney transplant recipients to support an
Drugs
FDA has cleared a BioStable Science & Engineering 510(k) for the HAART 300 Aortic Annuloplasty device, designed for aortic valve repair. It is intended to re-size, reshape, and stabilize the aortic annulus to “restore valve competence and help prevent recurrent aortic regurgitation,” according to the company. “Valve repair