FDA Policy/General
The Alliance for a Stronger FDA says the president’s FY 21 budget request for FDA, the House-passed bill, and the Senate’s new proposed bill have similar funding levels and a common core of initiatives for the agency to carry out in the new fiscal year if, as
FDA Policy/General
Federal Register notice: FDA is contemplating the grant of an exclusive patent license to Advion, Inc. (Ithaca, NY) for a government-owned patent for “Direct Impact Ionization Mass Spectrometry.” The license is limited to the manufacture and commercialization of a field-deployable mass spectrometer diagnostic for the rapid detection of
Drugs
FDA has posted an 11/6 safety labeling change for Genentech’s multiple sclerosis drug Ocrevus (ocrelizumab). The change affects the label’s Warnings and Precautions, Adverse Reactions, Use in Specific Populations, and Patient Counseling/Patient Information/Medication Guide sections.
Drugs
FDA’s recent emergency use authorization (EUA) for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients (see earlier story) contains GMP-related conditions the company must maintain due to concerns raised in two inspections conducted at its manufacturing
Drugs
FDA has awarded a research project to staff at the University of Maryland Smith School of Business to look at the risks to industry and government of returning drug manufacturing to the U.S. A statement from the university says the research will examine advanced manufacturing as a pathway to
FDA Policy/General
FDA has published a guidance, Documenting Electronic Data Files and Statistical Analysis Programs, to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. The document says its recommendations are intended to reduce the number of revisions that may
Drugs
FDA has cleared a SafKan Health 510(k) for its OtoSet Ear Cleaning System for removing impacted earwax. The device is an alternative to the time-tested ear bladder syringe. The device features a combination “irrigation and microsuction technology built into an automated and wearable device.” The company says it
Devices
Members of the FDA Ophthalmic Devices Panel voted 11/9 to recommend against approval of the Refocus Group’s VisAbility Micro Insert System with a proposed indication for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between 45 and 60 years old with specified manifest spherical
Devices
FDA says the Cook Medical 10/14 recall of its fixed core wire guide is Class 1. An agency statement says Cook recalled the product because five lots of wire guides dropped onto an unchecked surface during production. The notice said the drop could cause the wire guide to bend
FDA Policy/General
FDA commissioner Stephen Hahn reportedly is on thin ice with president Trump and HHS secretary Alex Azar after Pfizer’s announcement Monday of promising Covid-19 vaccine data (see earlier story). The Trump Administration has fired several senior officials at various Departments in the wake of last week’s election
Drugs
FDA has issued a Manual of Policies and Procedures (MAPP) establishing responsibilities and procedures for the controlled substance staff in the CDER Office of the Center Director to review research protocols sent to the staff from the Drug Enforcement Administration (DEA). The MAPP cites a regulatory requirement that HHS review
Drugs
A Council on Foreign Relations working paper says that a recent FDA rule to encourage drug importation from Canada won’t reduce drug prices or increase the volume of imported drugs. An analysis of the working paper in an online Regulatory Review post from the University of Pennsylvania Law School
Biologics
The Informed Consent Action Network (ICAN), generally cited as a leading anti-vaccination organization, is petitioning FDA to require changes in the study design for four Covid vaccines now in development to add additional efficacy requirements. The group’s 11/6 petition says the Phase 3 trial designs for the
Drugs
FDA commissioner Stephen Hahn says the agency has prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with Covid-19. Speaking 11/9 to the GRx+Biosims virtual conference, he also said FDA has worked closely with generic drug applicants whose development work has
Devices
Beyond Air says it has submitted a PMA application to FDA for its LungFit PH to treat persistent pulmonary hypertension of the newborn. A company statement describes LungFit as a cylinder-free, plastic flow nitric oxide generator and delivery system that could potentially replace large, high-pressure nitric oxide cylinders,
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on a drug-drug interaction assessment for therapeutic proteins provides helpful information to sponsors regarding assessing such interactions. “The opportunity for sponsors to consider the specifics of their particular therapeutic proteins in the context of specific indications and concomitant medications
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR Part 315” (OMB Control Number 0910–0409). The collection supports agency regulations in 21 CFR part 315 that require manufacturers of diagnostic radiopharmaceuticals to submit
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by OMB. The approved collections are: * Required Warnings for Cigarette Packages and Advertisements * Medical Devices; Reports of Corrections and Removals * Customer/Partner Service Surveys * Annual Reporting for Custom Device Exemption * Human Drug Compounding Under Sections
Drugs
Pfizer says the Phase 3 JADE REGIMEN study produced positive results for its atopic dermatitis investigational drug abrocitinib. The study involved patients age 12 and older with moderate to severe atopic dermatitis. A company statement says the study met its primary and key secondary endpoints. Abrocitinib is described as an
FDA Policy/General
A U.S. Senate Appropriations Committee-released bill for fiscal year 2021 proposes $3.21 billion in discretionary funding for FDA, which is about 3% ($90 million) less than the Trump Administration proposed in February (see earlier story). Nonetheless, the Senate bill is $50 million (1.6%) more than the
Devices
NightWare says FDA has given marketing permission through the de novo pathway for the company’s NightWare therapeutic platform that is the only medical device to be indicated for the temporary reduction of sleep disturbances related to nightmares in adults age 22 and older who suffer from nightmare disorder or
Drugs
FDA has approved a Sebela Pharmaceuticals NDA for Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, indicated for colonoscopy preparation. The product was designed to give patients and physicians an alternative to liquid-based colonoscopy preparations. Approval was based on data from two pivotal trials showing that 92% of