FDA Policy/General
Arguing that the drug industry “is as heavily regulated as it gets,” APCO Worldwide president of health care and former FDA associate commissioner for public affairs Wayne Pines urged the Trump White House 2/24 to heed industry advice and spare the agency the brunt of its government-wide deregulation.
Devices
FDA has granted a de novo petition request to allow marketing of Accelerate Diagnostics’ Pheno system and PhenoTest BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with
Drugs
Last year, CDER’s Office of Generic Drugs (OGD) approved the highest number of ANDAs in the history of the generic drug program – more than 800 submissions (including full and tentative approvals). Last year’s performance eclipsed 2015’s previous record of 726 ANDAs. In a new blog posting, OGD
Drugs
Research should be conducted on whether an off-label use of a medical product should be disclosed to patients under informed consent, according to University of Arizona law professor and faculty member of Harvard’s Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology Christopher Robertson. In a recent
FDA Policy/General
Federal Register notification of withdrawal: FDA has at the sponsor’s request withdrawn approval of a Putney, Inc. ANDA for mupirocin ointment 2% because the product is no longer manufactured or marketed. To view the notice, click here.
Drugs
A CDER Exclusivity Board memorandum explains the reasoning the agency followed in determining the scope of three-year exclusivity for Inspirion Delivery Technologies’ Morphabond (morphine sulfate) extended-release tablets. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the memo “details FDA’s
Drugs
Two Johns Hopkins University professors say that the European Medicines Agency’s (EMA) 2016 publication on its Web site of clinical study reports for carfilzomib (Amgen’s Kyprolis) and lesinurad (Ironwood’s Zurampic) puts pressure on FDA to change its long-standing position that such reports are confidential commercial information
Drugs
FDA has accepted a Novartis supplemental NDA for expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The submission is based on the primary
Drugs
FDA has approved an expanded indication for Celgene’s Revlimid (lenalidomide) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. The orally administered thalidomide analogue was originally approved in 2006 for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy.
Drugs
FDA 2/21 issued Dr. Reddy’s Laboratories a three-observation Form-483 after inspecting its Miryalaguda active pharmaceutical ingredients (API) plant in Telangana, India. The API plant was cited in a 2015 Warning Letter, and this presumably was a follow up inspection based on comments made late last year
Devices
FDA has cleared Accelerate Diagnostics’ PhenoTest BC Kit performed on the Pheno System, the first test to identify organisms that cause bloodstream infections and provide information about antibiotic sensitivity. An agency news release says that the test also reduces the amount of time needed to provide the information, which can
Devices
FDA has cleared a Seventh Sense Biosystems 510(k) for TAP, a new blood collection device. TAP is the world’s first push-button blood collection device that eliminates needle inserts to draw blood, according to the company. The small device is positioned on a patient’s upper arm and
Drugs
The House Energy and Commerce health subcommittee has announced a 3/2 hearing on “Examining FDA’s Generic Drug and Biosimilar User Fee Programs.” The hearing is part of the reauthorization process as both programs are set to expire 9/30. FDA and relevant stakeholders will provide testimony on how
Drugs
A group of physicians under the Mifeprex REMS Study Group are calling for FDA to withdraw a risk evaluation and mitigation strategy (REMS) program for the medical abortion drug Mifeprex because they say it no longer makes clinical sense. The distribution of Mifeprex “remains substantially and unnecessarily encumbered by a
Drugs
Spectral Medical says it plans to submit in the second quarter the last of four modules for a PMA for Toraymyxin, indicated for treating patients with endotoxemic septic shock. The therapeutic hemoperfusion device is designed to remove endotoxin, which can cause sepsis, from the bloodstream and is guided by the
Biologics
A new National Academies book, Human Genome Editing: Science, Ethics, and Governance, says that FDA is one of several agencies and organizations that have a significant role in regulating both somatic and germline human genome editing. The publication says that human genome therapies are considered to be gene therapies with
Drugs
A lengthy ProPublica report shows how major drug companies have quietly used academic researchers in public relations campaigns to support the high cost of some drugs. Many of the academics are leading economists and healthcare experts at major universities who also work for Precision Health Economics, it says. The report
Devices
Decision makers in medical device firms over- or under-react to market feedback through user-generated reports on adverse events related to their products and making product recall decisions, according to a detailed “big data” analysis reported in Production and Operations Management. The study authors say that the characteristics of
Drugs
FDA has issued Amphastar Pharmaceuticals a complete response letter on an NDA for naloxone hydrochloride 2mg/0.5mL nasal spray, indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The letter, according to the company, “identifies issues including
Drugs
FDA has accepted an Ocular Therapeutix NDA resubmission for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use for treating ocular pain occurring after ophthalmic surgery. The bioresorbable intracanalicular insert is intended for administration by a physician and is designed for drug release to the ocular surface for up to
Drugs
Pharmaceutical Research and Manufacturers of America says a proposed revision to an International Council for Harmonization addendum on Clinical Investigation of Medicinal Products in the Pediatric Population “is successful in addressing the many advances in pediatric drug development” since the ICH document was first promulgated. The comment letter says the
Devices
The FDA Circulatory System Devices Panel will consider 2/23 a Claret Medical De Novo 510(k) application for its Sentinel cerebral protection system for use in patients undergoing transcatheter aortic valve replacement (TAVR). The company is asking that the device be indicated for use as a cerebral protection device