FDA Policy/General
Reforms to FDA are part of six steps to transform healthcare now identified by the National Opinion Research Center (NORC) at the University of Chicago for the Healthcare Leadership Council. The group’s 2/17 report says there is a broad consensus in the U.S. among healthcare providers, payers,
Drugs
FDA has released a guidance on “Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations” to help sponsors understand how much safety data are needed from Phase 3 clinical trials, studies of new uses and long-term outcomes. The document discusses a “selective
Drugs
Stakeholders are calling on FDA to build more flexibility into a draft guidance on safety assessment for IND safety reporting. Pharmaceutical Research and Manufacturers of America (PhRMA) says that “there is a need for flexibility in designing systematic safety surveillance approaches, and therefore suggests that FDA revise the guidance to
Biologics
A lengthy and detailed report from the George Mason University Mercatus Center says that FDA has strayed from the drug, biologic, and medical device safety and effectiveness standards set out in the law due to “fear of being blamed for the failings of approved products.” The agency now, it says,
Drugs
FDA has posted a guidance on “Immunogenicity-Related Considerations for Low Molecular Weight Heparin (LMWH)” that provides recommendations on meeting the requirement for active ingredient sameness for ANDA for LMWHs. It includes recommendations on addressing impurities and their potential effect on immunogenicity for such ANDAs. Additionally, it includes recommendations on
Devices
FDA has approved Medtronic’s Deep Brain Stimulation (DBS) therapy for use in people with Parkinson’s disease of at least four years duration and with recent onset of motor complications, or motor complications that are not adequately controlled with medication. The device was originally approved in 2002 for use
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Substances Generally Recognized as Safe: Notification Procedure — 21 CFR 170.36 and 570.36,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selecting nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in CDRH notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on certain
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to require the filing of a PMA or a notice of completion of a product development protocol for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an
Drugs
Chugai Pharmaceutical Co. has decided to stop early a Phase 3 study involving Alecensa in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients after positive results were reviewed by an independent data monitoring committee. The committee recommended that the J-ALEX Study be stopped early after data
Drugs
Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in disseminating clinical trial results across leading academic medical centers, according to research published online in the open-access BMJ. Researchers from Yale and several other major universities looked at 4,
Devices
Bayer has disputed allegations leveled by Rep. Mike Fitzpatrick that a new report (see story) revealed unreported fetal deaths associated with the company’s controversial Essure permanent birth control device. On 2/17, Fitzpatrick released the report that cited 303 fetal deaths allegedly associated with the device, which he says
Drugs
A Texas federal court decision helped define off-label promotion by giving two examples of activities that don’t count as promotion. Attorney Elizabeth Minerd (Reed Smith) writes in a Drug and Device Law blog post that while in recent years there have been numerous cases discussing the legal ramifications
Biologics
CBER has accepted for priority review a Portola Pharmaceuticals BLA for andexanet alfa, indicated for reversing anticoagulant activity of both direct and indirect Factor Xa inhibitors. The user fee review target date is 8/17. Portola says the therapy should be used to reverse anticoagulation, such as in life-threatening
Drugs
Pharmakon has recalled one lot of its morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride 1 mL syringe because the product is super-potent. The recall follows recent laboratory results showing the product was super potent. “Injecting a patient with super-potent morphine could result
Drugs
Sandoz is asking the Supreme Court to decide whether the 180-day notice of commercial marketing required by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 can only be given after a proposed biosimilar product receives FDA approval. The company is appealing a Federal Circuit Court of Appeals
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products (CTP) is soliciting applications from regulated tobacco product manufacturers to participate in a voluntary pilot program to help CTP evaluate a potential new portal, the CTP eSubmissions Portal (CTP Portal), that is being designed to improve the process in connection with
FDA Policy/General
Federal Register Notice: The Science Board to the FDA will meet 3/1, from 8:30 a.m. until 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD. For those unable to
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 3/18 entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” Its purpose is to discuss approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in
Drugs
A Florida federal court has dismissed a number of claims brought by a plaintiff against Pfizer alleging that its Prempro caused her to develop breast cancer. Attorney Michelle Yeary (Dechert) writes in an online blog post that the pleading’s 36-page fact section appeared to be an attempt to
Devices
FDA has approved a St. Jude Medical PMA for the MultiPoint Pacing technology featured on the Quadra Assura MP cardiac resynchronization therapy (CRT) defibrillator, the Quadra Allure MP CRT-pacemaker and two new quadripolar Quartet LV leads. St. Jude says the new technology is designed to benefit CRT patients who
Drugs
FDA has issued Catalyst Pharmaceuticals a “Refusal to File” letter on its NDA for Firdapse (amifampridine phosphate), an investigational drug candidate for symptomatic treatment of Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS). The letter says that after a preliminary review, the agency determined that the submission was