Drugs
FDA has removed a partial clinical hold on a Adaptimmune Therapeutics planned study of its NY‑ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in myxoid round cell liposarcoma (MRCLS). The hold was issued in August as part of the agency’s request for additional chemistry, manufacturing and
Drugs
FDA has released the FDA-483 from a 9/14-10/14 Dallas District Office inspection at Cantrell Drug Co., an outsourcing facility, showing 12 violations. Specific inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
Devices
FDA has launched a new Web site to help sponsors and innovators to bring neurological medical devices to the U.S. marketplace. The agency says the Web site provides: * an overview of the FDA regulatory process and how it applies to developers and sponsors of neurological devices; * standards and guidances
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Approval was based on data from a randomized trial (CheckMate 141) comparing nivolumab with chemotherapy
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that as a first step in dealing with off-label information dissemination, FDA should create a clear safe harbor for manufacturer communications concerning new medicines and off-label uses of approved medicines with payers and other population health decision makers, “a highly
Devices
Consumers for Dental Choice has filed a citizen petition with FDA asking that the agency take steps to warn against amalgam use in children, pregnant women, and other sensitive populations by: * issuing a safety communication warning dentists, parents, and dental consumers against amalgam use in children, pregnant women, and other
Drugs
[Report by John Hope] Congressional observers see the possibility that a lame duck session of Congress opening 11/14 will fast-track approval of the 21st Century Cures legislation that has made its way in companion bills through both the House and Senate. With Republican control of both the House
Drugs
Sen. Chuck Grassley (R-IA) has asked the HHS inspector general to provide records on the 2009 identification of EpiPen’s misclassification that he says led to significant overcharging of taxpayers. Grassley also invited the inspector general to testify at an 11/30 Judiciary Committee hearing on the misclassification and
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing the review process for INDs and NDAs for botanical drug products and the role of the Center’s Botanical Review Team in the Office of Pharmaceutical Quality’s Immediate Office. The document says the policies and procedures “are intended
Devices
FDA has given 510(k) clearance to Syneron Medical’s Profound fractional radiofrequency microneedling device for use with the 75˚ SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types 1-3 as supported by long-term (six months) clinical data. The company says
Devices
FDA has given 510(k) clearance to Joimax’ Vaporflex and Legato electrosurgical probes with radiowave technology for open and endoscopic spine surgery. The German company says that the probes comprise a series of instruments to facilitate delivery of electrical energy from an RF generator to patient tissue for use in
FDA Policy/General
[Analysis by Jim Dickinson and David McFarland] Notwithstanding president-elect Donald Trump’s failure to publish a written policy platform, objective assessments of his public statements lead us to expect major changes in the way FDA does business with its regulated industries after his administration takes over in January. Actually,
FDA Policy/General
Federal Register Final Rule. FDA has amended certain regulations relating to citizen petitions, petitions for stay of actions and the submission of documents to the agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act that implement a congressional
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness.” The document discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. It says that a non-inferiority design is usually used because a
FDA Policy/General
FDA has denied a ProbioTech petition filed in April that asked the agency to change the definition of a dietary supplement under the Dietary Supplement Health and Education Act and to treat probiotic suppositories the same as oral probiotic dietary supplements. The petition says that probiotics that are not in
Devices
FDA has released a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling recommendations to promote the safe and effective use of aspirators. Ultrasonic surgical aspirator devices (aspirators) are surgical tools commonly used for a wide range of procedures to break down, liquefy, and
Drugs
Consumers visiting branded prescription drug Web sites may misinterpret information learned from clicking on disease awareness Web sites shown on the drug site. That’s the conclusion of a study reported in the Journal of Health Communications that was conducted by CDER staff and other researchers. The researchers found that
Biologics
Mylan has submitted a BLA for MYL-1401O, a proposed biosimilar copy of trastuzumab (Genentech’s Herceptin), indicated to treat certain HER2-positive breast and gastric cancers. The submission includes a comprehensive package of analytical similarity, nonclinical and clinical data, the company says. The clinical data consist of two pharmacokinetic
Drugs
FDA has accepted an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell disease. The submission is based on data from a Phase 3 study that demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction
Drugs
Two Forbes commentators say that FDA’s current “all-or-nothing” system for approving drugs hurts patients and should be replaced with a system of partial approvals. University of Chicago economist Tomas Philipson and University of Southern California pharmacy and public policy professor Darius Lakdawalla write that patients are hurt
Devices
House Energy and Commerce Committee members Diana DeGette (D-CO) and Susan Brooks (R-IN) have written FDA for information about how it is working to address potential cybersecurity vulnerabilities associated with medical devices. In a letter to FDA commissioner Robert Califf and CDRH director Jeffrey Shuren, DeGette and Brooks
Drugs
FDA has hired former Merck executive Peter Stein to serve as CDER Office of New Drugs (OND) deputy director effective 11/14. As OND deputy, Stein will work to set guidance and policy to ensure an efficient drug development and review process, which includes maintaining effective communications with regulated industry