Devices
Sens. Elizabeth Warren (D-MA), Patty Murray (D-WA), and Tina Smith (D-MN) are raising additional questions on the CDRH software pre-certification program after receiving the 6/19 response from FDA acting commissioner Ned Sharpless and CDRH director Jeffrey Shuren to the senators’ initial 10/18/18 questions.
Drugs
FDA has issued a draft guidance, Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, to give stakeholders information on the agency’s implementation of GDUFA 2. “Because GDUFA 2 created changes to the user fee program,” the document says, “this guidance serves to provide an explanation
Biologics
FDA has accepted for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum disorder. The rare, debilitating autoimmune disease of the central nervous system primarily damages the optic nerves and spinal cord, which can cause blindness, muscle weakness and paralysis. Those with the disorder
Drugs
FDA has issued a guidance, Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment, to assist sponsors in clinical development of drugs to treat chronic hepatitis D virus (HDV) infection. The document specifically addresses the agency’s current recommendations for the overall development program and clinical trial designs for the
FDA Policy/General
Federal Register notice: FDA has announced an 11/21 public meeting entitled “Office of Minority Health and Health Equity Public Meeting on Strategies to Improve Health Equity Amidst the Opioid Crisis.” The meeting is intended to share information and obtain public perspectives on the crisis and how it specifically affects
Devices
FDA is closing National Cybersecurity Awareness Month with a listing of key 2019 agency activities to ensure medical device cybersecurity safety and awareness. The post calls attention to these items: * convened a patient engagement advisory committee that sought recommendations on integrating medical device cybersecurity risk into health risk communications; * participated
Devices
FDA has granted Shreis Scalene Sciences a Breakthrough Device designation for Cytotron, a whole-body therapeutic medical device. The device is intended to be used to cause degeneration of uncontrolled tissue growth, the company says, and it is proposed for treating protein-linked, abnormally regenerating disorders such as neoplastic disease.
Drugs
FDA has granted a Recro Pharma appeal of the agency’s complete response letter issued for the NDA seeking approval for intravenous meloxicam. The company says the FDA letter said the appeal was granted “specific to the request … that the NDA provides sufficient evidence of effectiveness and safety to support
Drugs
ICU Medical has recalled one single lot of lactated ringer’s injection, USP, and one single lot of 0.9% sodium chloride injection, USP, due to the presence of particulate matter. “Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the
Drugs
FDA has granted CARsgen Therapeutics a Regenerative Medicine Advanced Therapy designation for its investigational CT053 CAR-T cell therapy and its use in treating relapsed and refractory multiple myeloma. The designation for the drug, a human anti-B cell maturation antigen, was based on clinical data from an ongoing Phase
Devices
FDA says an Ethicon 10/3 recall 8,256 of its Echelon Flex Endopath staplers due to a failure to completely form staples is a Class 1 recall. The company says it recalled the devices because some of them may contain an out-of-specification component within the device jaw
Drugs
CDER director Janet Woodcock says “advanced manufacturing technologies” could reduce U.S. drug maker reliance on foreign-sourced active pharmaceutical ingredients (APIs) and thus “enable U.S.-based pharmaceutical manufacturing to regain its competitiveness with China and other foreign countries.” Testifying before a 10/30 House Energy and Commerce Subcommittee
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER or CBER for serious and unexpected suspected adverse reactions
Drugs
In a split vote, FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has voted 9 to 7 to recommend that the agency remove from the market Amag Pharmaceuticals' accelerated-approval drug Makena (hydroxyprogesterone caproate injection) because a confirmatory trial failed to perform better than placebo to reduce the
Drugs
FDA has issued a guidance, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, with the agency’s interim regulatory policy concerning compounding by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act using bulk
Drugs
FDA has placed a partial hold on clinical trials for intrathecal administration of AVXS-101 following an AveXis communication to health authorities and clinical trial investigators based on findings from a small, AveXis-initiated pre-clinical study in which animal findings showed dorsal root ganglia mononuclear cell inflammation, sometimes accompanied
Devices
Innovative Health Solutions is asking FDA not to make a determination of certain subject devices’ substantial equivalence to the IB-Stim without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the IB-Stim in head-to-head evaluations. The 10/29 petition
Drugs
FDA has approved a Biogen 505 (b)(2) NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The NDA included data from pharmacokinetic bridging studies comparing Vumerity and the company’s Tecfidera to establish
Devices
FDA has granted Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter) device. The wrist-worn “arousal” device is designed to prevent respiratory arrest and death from opioid overdose. It is intended to continuously monitor SpO2 (blood oxygen levels) in post-operative patients and at-home
Devices
FDA has approved an Impulse Dynamics PMA supplement for its next generation of the implantable Optimizer Smart System for delivering cardiac contractility modulation therapy in heart failure patients. “New algorithms in the two-lead version of Optimizer Smart deliver therapy just as the previous device did, but no longer require
Devices
CDRH Office of Gastrorenal, OBGYN, General Hospital and Urology Devices clinical deputy office director Charles Viviano says CDRH uses a flexible approach in assessing the impact of uncertainty on benefit-risk determinations for PMAs, de novo submissions, and HDEs. Speaking on a 10/16 Webinar on a new “uncertainty guidance,
Drugs
A 3/19-4/5 FDA inspection at Petnet Solutions, Woburn, MA, found significant violations of current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drugs. A 10/17 Warning Letter says specific violations were: * the firm’s facilities are not adequate to ensure the prevention of contamination