Drugs
FDA has approved updates to Pfizer’s Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric events. The removal was based on data from the EAGLES study, the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder. Additional labeling revisions based
Drugs
The Department of Justice (DoJ) says it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2016, including $2.5 billion from the healthcare industry (drug companies, medical device companies, hospitals, nursing homes, laboratories, and doctors)
Drugs
FDA and Commonwealth Informatics have signed a new contract to support the use of advanced drug safety review tools at CDER and CBER. Under the new agreement, Commonwealth will support the expanded use of its “analytic suite of tools to help FDA manage their drug and product safety proactively and
Devices
FDA has cleared a St. Jude Medical 510(k) for its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sensor Enabled, a new cardiac mapping system. The device is “designed to provide automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart
Drugs
An FDA 12/15 final rule lists six substances the agency has evaluated and is proposing to include on a list of bulk drug substances that can be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The rule also lists four substances that the
Drugs
The HHS Inspector General finalized 12/7 a rule amending the safe harbor regulations under the federal healthcare program antikickback law and established exceptions to the civil monetary penalty prohibiting remuneration to Medicare and Medicaid beneficiaries. Attorneys Alan Kirschenbaum and David Gibbons (Hyman, Phelps & McNamara) write in their firm’
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a Web page for Spriaso’s Tuxarin ER (codeine phosphate and chlorpheniramine maleate) extended release tablets makes false or misleading claims or representations about risks associated with the drug and inadequately communicates its full indication. “This Web page is concerning
Drugs
The winner of a $40,000 cash prize in the 2016 FDA Naloxone App Competition was OD Help, developed by Team Pwrdby, a small startup based in Venice, CA. FDA associate commissioner for public health strategy and analysis Peter Lurie says the prize competition wanted to find innovative solutions to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a professional e-mail for United-Guardian’s Renacidin (citric acid, glucono, delta-lactone, and magnesium carbonate) irrigation solution makes false or misleading claims or representations about the product’s risks and benefits, misbranding it. A 12/13 Warning Letter
Drugs
CDER director Janet Woodcock does not appear too concerned with an Administration change next month, saying that for now it is business as usual and the work of the Center goes on. Speaking to CNBC reporter Meg Tirrell, Woodcock noted that she has been at FDA for over three decades
Drugs
The Washington Legal Foundation (WLF) is asking the California Supreme Court to reject a lower state court’s finding that Novartis could be held liable for injuries suffered by twins in utero after their mother took a generic version of an asthma medication (terbutaline) made by another company. A WLF
FDA Policy/General
FDA 12/15 announced the appointment of deputy associate commissioner for regulatory affairs Steven M. Solomon, DVM, as the new leader of the agency’s Center for Veterinary Medicine (CVM). He will assume the position next month from acting director Tracey Forfa, JD. who is currently serving as the Acting
FDA Policy/General
Federal Register Notice: FDA and HHS’s Office for Human Research Protections are making available a guidance entitled “Use of Electronic Informed Consent — Questions and Answers.” The document provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection related to “Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act — OMB Control Number 0910–0375.” A third party wishing to participate is required to submit a request for accreditation to the agency. Accredited third-
Drugs
The attorneys general from 20 states have filed a federal lawsuit that alleges six pharmaceutical companies violated antitrust laws by conspiring to fix prices and allocate markets for various generic drugs. The lawsuit was filed against against Heritage Pharmaceuticals, Inc., Aurobindo Pharma USA, Inc., Citron Pharma, LLC, Mayne Pharma (USA)
Devices
AdvaMed says that while it supports development of guidance by both FDA and the International Medical Device Regulators Forum (IMDRF) to help companies understand when clinical evaluation may be needed to demonstrate a reasonable assurance of safety and effectiveness for software intended for one or more medical purposes without being
Devices
FDA has partnered with the National Institutes of Health and the Department of Defense to more fully capture the patient experience with LASIK (laser-assisted in situ keratomileusis) and is using the data in a valid Web-based questionnaire that can be used to assess patients before and after surgery.
Drugs
Ten Hogan Lovells attorneys says the 21st Century Cures Act signed by President Obama unleashes “an expansive suite of measures designed to deliver new cures and treatments to patients.” They highlight key provisions in FDA’s regulation of drugs and biologics: * require HHS/FDA guidance on novel clinical trial designs;
Drugs
FDA says that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect development of children’s brains. An agency drug safety communication says recent human studies suggest that a
Drugs
Attorney James Beck (Reed Smith) says that his review of court cases and other sources indicates that preemption should apply to almost all warnings related to over-the-counter products for which there is at least a tentative monograph. “The same combination of a ‘sameness’ requirement and absence of any
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a direct-to-consumer TV ad for Sanofi-Aventis’ Toujeo (insulin glargine injection) U-300, for subcutaneous use, makes false or misleading representations about the risks associated with the drug. A 12/12 Notice of Violation says the violation “is
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a TV spot for Celgene’s Otezla (apremilast) makes false or misleading representations about the drug’s risks and is concerning from a public health perspective by creating a misleading impression about the drug’s safety. A 12/12 Notice