Drugs
FDA has accepted for review an Array BioPharma NDA for binimetinib for treating certain patients with melanoma. The agency has set a user fee review target date of 6/30/2017. The submission is based on data from the company’s Phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial
Devices
FDA has issued a safety alert for lab staff and health care professionals about a software defect in Sciex mass spectrometers. The defect may cause the devices to incorrectly assign results to samples analyzed. “This is of concern because health care professionals may make inaccurate clinical diagnoses or inaccurate medical
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Cardiovascular and Renal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA commissioner renews the charter of the Endocrinologic and Metabolic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA will hold a workshop 12/7 entitled “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.” Its purpose is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA’
Devices
The HHS Office of Inspector has posted a corporate integrity agreement between the government and Minneapolis-based Cardiovascular Systems Inc. (CSI) that follows an $8 million fine the company paid to resolve alleged illegal kickbacks to induce physicians to use its medical devices. The government alleges that CSI violated the
Drugs
GlaxoSmithKline says that while an FDA draft guidance on elemental impurities in drug products is a “well-written and informative document” that supports a risk-based approach to controlling elemental impurities, it is not up to date with respect to two U.S. Pharmacopeia (USP) chapters. “We assume that this
Biologics
FDA has scheduled for 12/7 a public workshop, “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program,” to describe the Sentinel Initiative and PRISM program, illustrate how the agency uses PRISM for regulatory responsibilities, and discuss PRISM’s future direction in terms of expansion and further integration into
Biologics
FDA has approved a Genmab supplemental BLA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for treating patients with relapsed chronic lymphocytic leukemia (CLL). The submission, which was given a priority review in May, was submitted by Novartis under a collaboration between the two companies.
Drugs
An Alabama federal court has granted Sandoz’ motion to dismiss a suit against it alleging that it failed to warn sufficiently about risks in use of amiodarone (a generic form of Wyeth’s Cordarone), off-label promotion, negligence, and failure to provide a Medication Guide to a man who died
Drugs
A 7/11 FDA draft guidance would allow ANDA holders to update drug labels with new safety information if the reference-listed drug (RLD) has been withdrawn by the branded manufacturer. Attorney Bradley Davidsen (Epstein Becker Green) writes in an online analysis that the draft represents a limited compromise between
Drugs
In November, FDA has planned a two-day public hearing to obtain input on off-label communication by drug and medical device companies. An FDA notice says the agency is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical
Drugs
FDA says that regulations generally prevent it from disclosing the existence of an IND or discussing much of the information in an IND file before the product is licensed. Thus, it says, it can’t respond substantively to a Rosalind Advisors 1/16 citizen petition asking that it place the
Drugs
FDA says it is requiring class-wide changes to drug labeling to inform healthcare providers and patients about the serious risks associated with combined use of certain opioids and benzodiazepines. An agency statement says that a Boxed Warning will be required, along with Medication Guides, for nearly 400 prescription opioid
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance, Submission of Warning Plans for Cigars. When finalized, it will help those involved in the manufacture, distribution, and sale of cigars in the U.S. understand the new cigar warning plan requirements under FDA’s final rule deeming these products
FDA Policy/General
Federal Register Notice: FDA is making available a guidance, Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry. The document is notifying blood establishments that collect whole blood and blood components, that FDA has determined Zika virus to be a relevant
FDA Policy/General
Federal Register Final rule: FDA is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless
Devices
FDA has cleared a Siemens 510(k) for the Somatom Drive computed tomography system, a new dual source scanner designed to deliver more precise imaging while reducing patient dose exposure. The device is equipped with the company’s Straton MX Sigma X-ray tubes and Sigma generators, which allow for
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have asked the Accredited Standards Committee X12 about steps it is taking to include medical device unique device identifiers on health insurance forms. “Collecting device identifiers on insurance claims forms would allow device performance and safety concerns to be tracked
Devices
The 5th Circuit Court of Appeals has upheld a Mississippi federal court’s grant of summary judgment to Lanx Inc. in a state law suit involving its Telluride system. A patient in whom the system was implanted to fuse spinal vertebrae filed the suit after screws in the system fractured
Devices
A 6/17-7/7 FDA inspection at Simpro, Irving, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s importing and distributing of non-invasive blood pressure monitors, fingertip pulse oximeters, and portable fetal Dopplers. An 8/17 Warning Letter from the agency’s Dallas
Drugs
FDA inspections at China’s Xinxiang Pharmaceutical Co. (9/14-16/15) and Xinxiang Tuoxin Biochemical Co. (9/15-18/15) found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs), according to an 8/19 Warning Letter. Specific deviations cited in the letter include: * failing