Drugs
FDA has issued Indian drug maker Ipca Laboratories a Warning Letter over GMP issues at three of its drug manufacturing plants — Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa). The facilities were inspected in 2014 and 2015, and they have been under an import alert since early last year.
Drugs
Allergan and AstraZeneca have entered into a global agreement to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic containing aztreonam and avibactam. Under the pact, the companies say they will evaluate the combination to treat serious infections caused by metallo βlactamase MBL-producing Gram-negative pathogens, a difficult-
Drugs
CDER is urging drug manufacturers to “adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective,” which would also help prevent drug shortages. In a 2/1 blog posting by CDER Office of Pharmaceutical Quality director Michael Kopcha, he says the agency has recently established
Devices
Beginning this month, CDRH will accept global unique device identifier database (GUDID) account requests from labelers of Class 2 devices. “FDA’s experience and feedback from industry indicate that device labelers often take a number of actions to organize, collect and validate data — before they get a GUDID account or
Drugs
The Obama Administration is aiming to spend upwards of $1 billion on vice president Joe Biden’s cancer moonshot initiative (see earlier story). Already, $200 million was included in December’s omnibus spending package, and another $755 million will be sought 2/9 when the president presents his FY 2017
Drugs
German researchers have developed an “on-dose marker technology” based on polyethylene glycols (PEGs), a commonly used pharma excipient, as a new approach to possibly thwart drug counterfeiters. Writing in the European Journal of Pharmaceutics and Biopharmaceutics (2/2016), the researchers describe a technique in which they incorporated combinations of
FDA Policy/General
Friends of Cancer Research says politics is getting in the way of the Senate’s confirmation of Robert Califf to be the next FDA commissioner. The group urges the Senate to quickly approve the nomination because the country is at a public health “pivotal moment” and needs a strong commissioner
Drugs
FDA has announced an import alert on genetically engineered (GE) salmon that would likely lift a hold on FDA commissioner-nominee Robert Califf that was placed by Lisa Murkowski (R-AK) last month until she received reassurances from the agency that GE salmon will be labeled as such. The import
FDA Policy/General
Federal Register Notice: FDA’s Psychopharmacologic Drugs Advisory Committee will meet 3/29 from 8 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss the specific risk-
Devices
FDA has approved a LivaNova PMA for its stented aortic bioprosthesis Crown PRT for treating aortic valve disease. The device features a “surgeon-friendly design, optimizing hemodynamics and the patented Phospholipid Reduction Treatment (PRT), which was designed to enhance valve durability,” the company says. The valve also allows, it says,
FDA Policy/General
BIOLOGICS Info on Xenotransplantation Sent to OMB Federal Register Notice: FDA’s proposed collection of information, “PHS Guideline on Infectious Disease Issues in Xenotransplantation,” has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. To view this notice,
FDA Policy/General
FDA’s Center for Veterinary Medicine 1/29 simultaneously announced the approval of the first animal drug (levothyroxine) to treat canine hypothyroidism and its issuance of Warning Letters to six manufacturers of unapproved veterinary levothyroxine products for this condition. The newly approved product, Thyro Tabs Canine, is made by Shenandoah,
Drugs
Alabama residents David Allen, a former pharmacist-in-charge of the now-defunct compounding pharmacy Advanced Specialty Pharmacy doing business as Meds IV, and William Timothy Rogers, a pharmacist and former president of Meds IV, have agreed to plead guilty to charges for their role in distributing adulterated drugs to
Drugs
FDA and NIH have developed a glossary that clarifies important definitions and describes some of the hierarchical relationships, connections, and dependencies among the terms “biomarkers” and “clinical assessments.” The two agencies developed the BEST (Biomarkers, EndpointS, and other Tools) Resource glossary that “aims to capture distinctions between biomarkers and clinical
Drugs
The House Energy and Commerce Subcommittee on Health has scheduled a 2/4 hearing on “Examining Implementation of the Biologics Price Competition and Innovation Act.” The 2010 law established a new abbreviated approval pathway at FDA for biological products determined to be “biosimilar” or “interchangeable” with a previously FDA-licensed
Drugs
FDA has approved a Merck NDA for Zepatier (elbasvir and grazoprevir) with or without ribavirin for treating chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Approval is based on clinical trial data from 1,373 participants with chronic HCV genotype 1 or 4 infections with
Devices
FDA has posted a transcript of a 1/21 Webinar detailing CDRH’s recent guidance on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings. “The terminology used to describe gowns has evolved, making it important for both industry and gown users to have a clear and
Devices
Arkray Factory has begun a Class 1 recall of its SpotChem II Test Strips due to inaccurate blood sugar readings. The reagent test stripa are used to glucose levels in blood samples, and are used with the SpotChem EZ analyzer. A recall notice says the strips are falsely showing low
Drugs
The White House has established a Cancer Moonshot Task Force to be led by vice president Joe Biden, with representatives from 13 government agencies, including FDA, National Institutes of Health and National Cancer Institute. President Obama pledged a moonshot-type effort to cure cancer during his State of the Union
Drugs
Washington Legal Foundation (WLF) says that recent federal appeals court decisions suggest that the Supreme Court’s 2011 decision in Sorrell v. IMS Health has led to an expansion of commercial speech. A WLF online Legal Pulse says that the high court held in Sorrell that content- or speaker-based
Drugs
FDA should not have much say in drug pricing issues, such as expediting new applications for a competing product once a pricing spike has occurred in the marketplace, according to CDER director Janet Woodcock. Testifying at a Senate Health, Education, Labor and Pensions Committee hearing on the generic drug user
FDA Policy/General
As FDA commissioner nominee Robert Califf moves closer to a full Senate confirmation vote, another lawmaker has announced opposition to the appointment. This time it is Sen. Joe Manchin (D-WV), who says he will filibuster Califf’s nomination because of his strong ties to the pharmaceutical industry. Manchin says