Drugs
The 2016 first quarter Stericycle Recall Index says that the number of recalled drug and medical device units dropped significantly in the quarter. The analysis shows that while the number of drug recalls remained consistent with the historical average, the number of units affected dropped to the second lowest quarter
Drugs
Healthcare Supply Chain Association president Todd Ebert says that the backlog of generic drug applications at FDA is contributing to the problem of drug price increases. Writing in a letter to the New York Times, Ebert says that his association supports legislation (S. 2615, the Increasing Competition in Pharmaceuticals Act)
Drugs
FDA has again postponed its final rule on generic drug post-approval labeling changes, this time until 4/2017. Public Citizen previously criticized the agency for delaying the rule’s issuance until 7/2016. The group has long complained (see earlier news release) that brand name drug manufacturers currently are
FDA Policy/General
Federal Register Notice: The FDA has renewed the charter of the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/13/18. To view this notice, click here.
Drugs
FDA has issued a drug safety alert that warns healthcare professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets for unapproved uses to treat skin and nail fungal infections. “Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines
Devices
The Campaign for Mercury Free Dentistry has petitioned FDA to amend its mercury amalgam rule to require patient labeling for dental amalgam. The petition urges the agency to require manufacturers to distribute patient labeling containing information on (1) amalgam’s mercury content; (2) amalgam’s risks to children and fetuses;
Drugs
Celator Pharmaceuticals says it plans to file an NDA in the third quarter of this year for Vyxeos (also known as CPX-351), an investigational drug in development for treating acute myeloid leukemia (AML) and other blood cancers. The agency recently granted the therapy a breakthrough designation based on positive
Drugs
FDA has approved a Boston Scientific PMA for its Precision Montage MRI Spinal Cord Stimulator (SCS) System which is intended to help relieve chronic pain while also enabling safe access to full body magnetic resonance imaging in a 1.5 Tesla environment. The device uses the company’s MultiWave technology
Drugs
The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures (MAPP) on applying three International Council on Harmonization (ICH) principles to chemistry, manufacturing, and controls review of drug applications. The MAPP says the ICH Q8(R2) document published 11/20/09 provides information on how to
Drugs
A Rhode Island federal judge has ordered FDA to allow experimental cancer trial treatments to resume for a 20-year-old man while a full hearing on the case is scheduled. The Providence Journal reports that FDA had shut down a clinical trial at the Burzynski Research Institute in Texas
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 6/28, from 8 a.m. to 5 p.m., at Hilton Washington DC/Rockville Hotel & Executive Meeting Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD. The committee will discuss two Boehringer Ingelheim
Drugs
Several stakeholders are asking FDA to make substantive changes to a draft guidance on implementing the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council say that although they agree with many aspects
FDA Policy/General
NIH has issued four new grants to support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic information. “The projects will examine the use of genomic information in the prevention and treatment of infectious diseases; genomic information privacy; communication
Devices
Alcon has recalled its LenSx Laser System, indicated for use in patients undergoing cataract surgery and refractive surgery, after receiving reports concerning incomplete corneal flap creation. An FDA recall notice says the device errors are related to a “software design (manufacturing process).” The company has sent users a recall notification
Drugs
FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) for treating people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months after receiving chemotherapy. Urothelial carcinoma accounts for 90% of all bladder cancer. Approval
Drugs
FDA has issued a drug safety alert on Janssen’s diabetes medicines containing canagliflozin (Invokana and Invokamet) after data from an ongoing clinical trial showed an increase in leg and foot amputations, mostly affecting the toes. The ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) identified amputations that occurred about twice as
Drugs
Oramed Pharmaceuticals has announced “positive top-line results” from its Phase 2b study that was designed to evaluate the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with Type 2 diabetes. The study’s primary endpoint, a significant reduction in weighted mean night-time glucose, was
Devices
Roche has filed a 510 (k) for a fully automated assay for detecting antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing systems, including the cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers. The assay
FDA Policy/General
A Senate Appropriations subcommittee has approved a 2017 funding bill that would provide FDA $2.8 billion in discretionary spending, a $39 million (1%) increase over fiscal year 2016 spending levels. Including revenue from user fees, total 2017 funding is $4.78 billion, which is $103 million above FY2016. Within
Drugs
A 6/1-6/12/15 FDA inspection at Lincare Holdings (United Medical Home Infusion), Little Rock, AR, found “serious deficiencies” in the firm’s practices for producing sterile drug products, putting patients at risk, according to a 4/25 Warning Letter from the agency’s Dallas District Office. The
Drugs
FDA’s New York District Office says that Super Power Khan, distributed as a dietary supplement by Economax, Flushing, NY, through a Web site, is an unapproved new drug that also is misbranded. A 5/6 Warning Letter says that the agency confirmed through laboratory analysis that a sample of
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations. It is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-