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The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on a drug-drug interaction assessment for therapeutic proteins provides helpful information to sponsors regarding assessing such interactions.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
Drugs
FDA has granted fast track designation for Surface Oncology’s SRF 388 for treating patients with hepatocellular carcinoma who have been previously treated with standard therapies such as vascular endothelial growth factor targeted agents and programmed death-ligand blockade. The company says SRF 388 is enrolling patients with advanced solid
Drugs
FDA has cleared a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment and machine learning digital platform that monitors and assesses the heart, lungs, and upper vascular system. “Gender-neutral and size adjustable, the SimpleSense platform effectively replaces the digital stethoscope, multi-
Drugs
FDA has issued Eli Lilly an emergency use authorization (EUA) for its investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients. The therapy is authorized for patients 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and
Drugs
A 2/24-2/28 FDA inspection at the Nartex Laboratorios Homeopaticos drug manufacturing facility in Coahuila de Zaragoza, Mexico, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. An 11/4 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and
Drugs
Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive topline results in the Phase 3 NAVIGATOR trial. A statement from the companies says tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. The statement says the drug was very well tolerated
Drugs
With FDA pausing many foreign drug manufacturing facility inspections due to the Covid-19 pandemic, Sens. Elizabeth Warren (D-MA) and Tina Smith (D-MN) are asking the agency for information on the inspections still being held and measures being taken to protect FDA staff who conduct those inspections. In
FDA Policy/General
Federal Register notice: FDA has made available a revised final guidance on “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” The guidance supersedes the now withdrawn and same titled final guidance issued in 5/2018. The revision removes Section VI.B. regarding the “same product as
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Regulatory Considerations for Microneedling Products. The document is intended to assist industry in understanding when a microneedling product is a device as defined in the federal Food, Drug, and Cosmetic Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance recommends approaches that sponsors of clinical trials intended to support an NDA/BLA to increase enrollment of underrepresented populations in their clinical trials.