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
FDA Policy/General
Federal Register notice: FDA has announced a 12/3-4 Science Advisory Board to the National Center for Toxicological Research (NCTR)advisory committee meeting. On 12/3, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. An overview of a subcommittee
FDA Policy/General
Federal Register notice: FDA has classified continuous glucose monitor data management systems into Class 1 (general controls). The classification decision is based on a 2014 Dexcom, Inc.-submitted request for De Novo classification of its Studio on the Cloud Data Management Software. FDA has identified the system as an electronic
Drugs
AstraZeneca has announced positive progression-free survival (PFS) results from the Phase 3 POSEIDON trial in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) for Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy. “The trial met a primary endpoint by showing a statistically
Devices
Medtronic has received an FDA Breakthrough Device designation for its fully implantable left ventricular assist device (LVAD) for patients with advanced heart failure. Currently, LVAD systems include an implanted heart pump that is connected to a driveline cable that extends outside the body to a controller, which is connected to
Drugs
FDA has issued a draft guidance, Providing Regulatory Submissions in Electronic Format: IND Safety Reports, describing the electronic format sponsors will be required to use when they electronically submit to FDA IND safety reports for serious and unexpected adverse reactions. The document implements the electronic submission requirements of Section 745A(
Drugs
An interagency drug shortage task force led by FDA has identified three root causes for drug shortages and “enduring solutions” to address such shortages. The report relies on information from stakeholders, published research, and economic analysis of market conditions affecting drug shortages, FDA says. The three root causes identified are:
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry entitled “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.” The document explains when a Type V DMF may be used to submit information regarding a combination product for which CDER
FDA Policy/General
Federal Register notice: FDA has classified self-fitting air-conduction hearing aids into Class 2 (special controls). The classification was made based on a 5/2019 Bose Corp.-submitted De Novo classification request for the Bose Hearing Aid. FDA has identified such aids as a wearable sound amplifying device that
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. The basis for the proposal is that the company has repeatedly failed
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. The basis for the proposal is that the company has repeatedly failed to submit required
Biologics
A Pew Trusts report, “FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight,” says the agency’s 2017 guidance documents that constitute its regulatory framework “marks an important step in the agency’s efforts to encourage the development of new therapies while also protecting patients from dangerous unapproved interventions.
Drugs
An Idaho district court has rejected the theory of “innovator liability” under which a branded drug manufacturer can be held liable for injuries caused by a generic version of its drug. A Washington Legal Foundation (WLF) Legal Pulse reports that the court ruled that plaintiffs could not sue Novartis for
Drugs
Reps. Frank Pallone (D-NJ) and Brett Guthrie (R-KY) have introduced H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019. The bipartisan legislation would allow FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: PetNet Solutions, Knoxville, TN (10/17): FDA inspected the firm’s Woburn, MA drug manufacturing facility and cited significant GMP violations for
Devices
FDA has cleared a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams. The clearance is based on data from a recent multi-center, outcome-based study (MR-INFORM), published in the New England Journal of Medicine, that “demonstrated that non-invasive
Drugs
FDA has accepted for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain. The agency has set a user fee review action date of 3/26/2020. The NDA was resubmitted based on feedback from an FDA/company meeting that sought clarity on
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Categorization — 42 CFR 493.17” (OMB Control Number 0910-0607). The collection is described in a guidance under the same title, which discusses procedures FDA uses to