Drugs
FDA has issued a guidance, REMS: FDA’s Application of Statutory Factors in Determining When a REMS is Necessary, to clarify how the agency applies the factors from the Federal Food, Drug, and Cosmetic Act to determine whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that
FDA Policy/General
Federal Register notice: FDA is proposing a new information collection on “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The collection is intended to support recommendations found in the same-titled agency guidance, which outlines the requirements and recommendations for
Drugs
FDA has released a list of 40 angiontensin II receptor blockers (ARBs) for which the agency has reached the conclusion that they do not contain any known nitrosamine impurities. In a statement linking to the list and other documents, FDA commissioner Scott Gottlieb and CDER director Janet Woodcock say they
Drugs
FDA has approved a Pfizer supplemental NDA for Ibrance (palbociclib) capsules and their use in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients. The drug was initially approved in 2015 for treating certain women
Drugs
FDA has accepted for review a Kyowa Hakko Kirin resubmitted NDA for KW-6002 (istradefylline), an investigational selective adenosine A2A receptor antagonist for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes. The agency 2/2018 rejected the submission, citing concern about
Drugs
FDA has extended by three months the review of a Daiichi Sankyo NDA for quizartinib, an investigational FLT3 inhibitor currently under priority review for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The extension is necessary for FDA to review a agency-requested data submission, according
FDA Policy/General
Federal Register notice: FDA has announced a 5/31 public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, and labeling of products containing cannabis or cannabis-derived compounds. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to its “Guidance: Emergency Use Authorization of Medical Products and Related Authorities” (OMB Control Number 0910-0595). The guidance describes the agency’s policies applicable to emergency use authorizations of the of certain medical products. It says
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance entitled “Medical Device Accessories” (OMB Control Number 0910–0823). The document addresses the regulation of accessories to medical devices and describes FDA’s policy concerning the classification of accessories. It also describes the processes
Biologics
FDA has released the FDA-483 issued following a 9/17-9/21/18 agency inspection at Liveyon, a Yorba Linda, CA, “own label stem cell distributor.” The inspection observations were: * adverse reactions that involved a communicable disease related to an HCT/P (human cells, tissues, or cellular or tissue-
Devices
FDA has approved a TherOx PMA for its SuperSaturated Oxygen (SSO2) Therapy that is intended to provide interventional cardiologists with a treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in heart attack patients. The therapy delivers hyperbaric levels of oxygen directly to ischemic heart muscle immediately after
Devices
FDA has issued a Warning Letter to Inova Genomics Laboratory for illegally marketing certain genetic tests that have not been reviewed by FDA for safety and effectiveness. An agency media statement says the tests claim to predict patients’ responses to specific medications based on genetic variants. “Selecting or changing drug
FDA Policy/General
A Health Affairs article assesses FDA commissioner Scott Gottlieb’s nearly two years in office in terms of his efforts to advance policy in three areas relating to prescription drugs, and then looks ahead to how the agency may change under Ned Sharpless. The three drug policy areas considered are
FDA Policy/General
Outgoing FDA commissioner Scott Gottlieb, who was a resident fellow at the American Enterprise Institute (AEI) conservative think tank before being named to head FDA, is returning to AEI to focus on drug prices. In an interview with the Washington Post, Gottlieb said he is interested in trying to determine
FDA Policy/General
FDA has released 30 years of adverse event reports related to animal drugs and medical devices used in animals. The reports are available online here. An agency announcement of the release says the action “is part of a broader effort by the agency to increase the transparency and sharing of
Drugs
FDA has cleared a Magstim 510(k) to include intermittent Theta Burst Stimulation (iTBS) as a treatment for Major Depressive Disorder with its Horizon TMS Therapy system. The clearance allows Magstim to market the three-minute iTBS protocol, along with current options for standard repetitive Transcranial Magnetic Stimulation (TMS), which
Drugs
The American Association of Pro-Life Obstetricians and Gynecologists and the American College of Pediatricians are petitioning FDA to restore and strengthen elements of the Mifeprex (mifeprostol) regimen and prescriber requirements approved in 2000 and retain the Mifeprex REMS limiting dispensing of the drug to patients in clinics, medical offices,
Drugs
FDA has approved its first “Parallel Systems REMS” as part of the approval of four generic versions of Gilead’s Letairis (ambrisentan) for treating pulmonary arterial hypertension. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that FDA explained that three generic manufacturers of
FDA Policy/General
Federal Register notice: FDA has announced a 5/13 public hearing to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Bayer’s Chlor–Trimeton Allergy 12 Hour (chlorpheniramine maleate) extended release tablets 8mg and 12mg were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will continue to approve ANDAs that refer to the product as long
FDA Policy/General
Federal Register notice: FDA has determined that Lundbeck Pharmaceuticals’ Onfi (clobazam) tablets 5mg were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the drug product, if all other legal and regulatory requirements are met. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Technical Electronic Product Radiation Safety Standards Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/24/2020. To view the notice, click here.