Drugs
Attorneys Benjamin Zegarelli and Eli Greenspan (Mintz Levin) say that an FDA 1/9 final rule amending the definition of “intended use” for drugs and medical devices, which could be subject to congressional rollback, is something that industry might prefer to keep on the books. Writing in an online blog
Drugs
In a three-year progress report on its regulation of drug compounding under the Drug Quality and Security Act of 2013, FDA says its oversight efforts have had a significant public health impact. The report lists these accomplishments: * significantly increased agency inspections of facilities where drugs are being compounded with
Devices
FDA has cleared a SonaCare Medical 510(k) for its latest version of Sonablate, a high-intensity focused ultrasound device intended for focused ablation of prostate tissue. The company says the improved device includes new and updated features such as: Tissue Change Monitoring, a tool that quantifies radiofrequency signals for
Drugs
A QuintilesIMS Institute report on “Lifetime Trends in Biopharmaceutical Innovation” says that from a numerical perspective and anticipating the progress of drug candidates currently in the research and development pipeline, the state of biopharmaceutical innovation is robust. The report says that a total of 667 innovative biopharmaceuticals launched in the
Drugs
CDER has posted a list of 101 new and revised draft guidances in 16 categories it plans to publish in FY 2017. Categories, with the number of planned guidances, are advertising (1), biopharmaceutics (3), biosimilarity (2), clinical/antimicrobial (1), clinical/medical (11), clinical pharmacology (8), clinical/statistical (3), drug safety
Devices
FDA says it has received reports of serious adverse events, including patient injury and death, associated with use of implantable infusion pumps in the magnetic resonance (MR) environment. An agency safety communication says the reports describe medication dosing inaccuracies such as over- or under-infusion and unintended bolus, and other
Drugs
FDA has accepted Mylan’s BLA for a proposed biosimilar trastuzumab (Genentech’s Herceptin), indicated to treat certain HER2-positive breast cancers. The company says that the anticipated FDA goal date under the Biosimilar User Fee Act is 9/3.
Drugs
A Tufts Center for the Study of Drug Development survey says that poor doctor and nurse engagement is driving low patient recruitment for clinical trials. Survey results reported (purchase or subscription required) in the center’s Impact Report indicate that while doctors and nurses have a high familiarity and comfort
Devices
Bayer has begun a Class 1 recall of its Medrad Intego PET Infusion System Source Administration Sets due to particulates generated in vials. The particulates may be created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter
FDA Policy/General
Federal Register Notice: FDA has announced the availability of a draft guidance entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” The document is intended to promote the safe use of nonprescription aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and
FDA Policy/General
Federal Register Notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The drug substances are recommended to be placed in Schedule I of the Single Convention on Narcotic Drugs (1961). To view the
Drugs
Galena Biopharma says it faces greater risks as it learns more about a 12/16/15 subpoena from the U.S. Attorney in New Jersey for records relating to the company’s marketing and promotional practices for Abstral (fentanyl), which it sold in the fourth quarter of that year. The
FDA Policy/General
FDA commissioner Robert Califf plans to officially resign on Inauguration Day (1/20), according to the agency. While FDA is being tight lipped on his replacement, it is assumed that next-in-line deputy commissioner Stephen Ostroff will take the reigns as acting commissioner — a position he handled after former
Drugs
Merck and Incyte Corp. have announced plans to advance the clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. The companies say they plan to begin pivotal studies of epacadostat in combination with Keytruda in
Biologics
New CBER director Peter Marks says that in FY 2016, the Center enhanced its operational efficiency, which facilitated getting new treatments to the public. In an annual report, Marks says that as of 9/30/16, CBER exceeded its regulatory performance target by completing 100% of standard and priority reviews
FDA Policy/General
The Federal Trade Commission and the New York State attorney general have filed claims in a New York federal court charging the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is “clinically shown” to work. FTC says
Drugs
FDA says it has approved Egalet’s Arymo ER (morphine sulfate extended-release tablets), indicated to treat pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. An agency statement says the drug has physiochemical properties expected to make
Drugs
FDA says it is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups, and genders. An agency Consumer Update says that overall, few people sign up for and participate in trials, and those who do participate don’t always represent the U.S.
Drugs
FDA has released a guidance on “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.” The guidance is based on a 2013 drug safety alert that warned about the use of acetaminophen and its association with rare but serious skin reactions. These
Drugs
FDA has made available a final guidance entitled “Current Good Manufacturing Practice Requirements for Combination Products.” The document describes and explains GMP requirements for combination products, which published in the Federal Register 1/22/2013. It also includes general considerations for maintaining GMP compliance, as well as analysis of hypothetical
Drugs
Sens. John McCain (R-AZ) and Amy Klobuchar (D-MN) have reintroduced their Safe and Affordable Drugs from Canada Act that they say would allow individuals to safely import prescription drugs from Canada. Under the legislation, prescription drugs would have to be purchased from an approved Canadian pharmacy and dispensed