FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by OMB. They are: * Accreditation Scheme for Conformity Assessment Pilot Program * General Administrative Practice and Procedures * Records and Reports Concerning Experience With Approved New Animal Drugs * Adverse Event Program for Medical Devices (Medical Product Safety
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. To view the notice, click here.
Drugs
FDA has approved an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair. The company describes Xaracoll as a unique, non-injectable drug-device combination in the form of a bioresorbable collagen implant containing
Devices
International Contrast Ultrasound Society (ICUS) has petitioned FDA to remove Boxed Warnings from ultrasound contrast agents (UCAs), citing scientific data to demonstrate product safety and life-saving potential. “It is now abundantly clear that UCAs are extremely safe, and that they may save lives and lower overall diagnostic imaging costs,
Devices
FDA has approved Medtronic’s MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in individuals aged two to six with Type 1 diabetes. The 770G System is a Bluetooth-enabled version of previously approved MiniMed
Devices
FDA has granted Baxter International a de novo application for the Theranova dialysis membrane. The company says the device was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis filters, like high-flux membranes, by “targeting effective removal of conventional
Drugs
As several Covid-19 vaccines move into final safety-efficacy demonstrations, FDA commissioner Stephen Hahn says it is possible that an emergency use authorization (EUA) could be granted before Phase 3 clinical trials are completed. In an interview with the Financial Times, Hahn said such actions will be transparent, grounded
FDA Policy/General
Quidel has entered into definitive agreements to acquire for $400 million the Triage MeterPro cardiovascular and toxicology assets and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers from Alere Inc. The products are being divested in order to obtain antitrust approvals required for Abbott’s
FDA Policy/General
Federal Register notice: FDA has announced a 10/9 joint meeting of its Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Panel members are scheduled to discuss the efficacy, safety, and benefit-risk profile of an Alkermes NDA for olanzapine and samidorphan oral tablets, indicated for
Devices
FDA has issued a draft guidance on Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. The document discusses best practices for incorporating patient-reported outcome (PRO) instruments throughout a medical device’s lifecycle. It touches on the qualities of PRO instruments
FDA Policy/General
Federal Register notice: FDA has announced a 10/22 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss the development, authorization and licensure of Covid-19 vaccines. The agency says no specific application will be discussed at the meeting. To view the notice, click here.
Drugs
FDA has published new product-specific guidances (PSGs) that provide recommendations for developing generic drugs and generating data needed to support ANDA approval. The latest batch include 19 new and 17 revised PSGs. Specifically, FDA is revising the PSG on liposomal amphotericin B injection, an antifungal used to treat fungal
Drugs
FDA commissioner Stephen Hahn has removed newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 he made at an 8/23 White House press conference. Miller was installed at FDA by the White House less than two
Devices
FDA has granted Synchron a breakthrough device designation for Stentrode, an implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel without the need for open brain surgery. The device is currently being evaluated for its ability to enable patients with paralysis
Devices
FDA 8/28 issued an alert to healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-based Laws of Motion PPE.com until further notice because they may not provide their labeled level of protection, including fluid barrier protection. The agency’s
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases. The document provides recommendations on clinical trial designs for drugs and biological products that are intended to support product labeling describing the antitumor activity in patients with central nervous
Drugs
FDA has approved a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older. The approval represents the first new mechanism of action for an acne drug in almost 40 years, the company says. The drug targets the androgen receptors directly in the skin
Drugs
The Justice Department says Teva is the seventh generic drug manufacturer to be charged with conspiring to fix prices, rig bids, and allocate customers for generic drugs. A department statement says a superseding indictment filed 8/25 in a Pennsylvania federal court alleges that the company participated in three conspiracies
Devices
FDA has cleared a B. Braun Medical 510(k) for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within magnetic resonance imaging (MRI) suites. The device is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to
Devices
FDA has granted an emergency use authorization (EUA) for the Abbott BinaxNOW Covid-19 Ag Card, described as a fast, $5, 15-minute, easy-to-use Covid-19 antigen test. The company says it is offering a no-charge complementary phone app that allows people to display their BinaxNOW test
Devices
FDA has approved Foundation Medicine’s FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test. The company says the approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP (poly ADP ribose polymerase) inhibitor approved in a prostate cancer setting, and three tyrosine kinase inhibitors for non-small
Devices
Public Citizen is suing FDA to compel the agency to respond to the advocacy group’s 2015 petition asking that Baxter’s Seprafilm Bioresorbable Membrane be banned. Seprafilm is a material used by surgeons during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissue that