FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Richard M. Simon from providing services in any capacity to a person that has an approved or pending drug product application. In January, Simon was convicted on one count of racketeering conspiracy related to his role as regional sales manager
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) has updated its core launch review process as explained in new frequently asked questions. OPDP says it has been evaluating trends in core launch material submissions such as sales and visual aids, patient brochures, and professional journal and magazine ads from sponsors
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees” (OMB Control Number 0910–0776). The collection supports FDA’s policy allowing drug products compounded in
Drugs
The HHS Office of Inspector General (OIG) says it has significant concerns about companies offering or paying remuneration, and healthcare professionals (HCP) soliciting or receiving remuneration, in connection with speaker programs. “Based on our investigations and enforcement actions,” an OIG fraud alert says, “this remuneration is often offered or paid
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 19 NDAs from multiple applicants. That notice indicated that FDA was withdrawing R2 Pharma’s NDA 202342, esomeprazole strontium delayed-release capsules. Because of clerical errors in the agency’
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Electromagnetic Compatibility of Medical Devices. The document describes relevant information that should be provided in device premarket submissions. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Family Pharmacy, Statesville, NC (11/6): FDA inspected the firm 2/3-2/12 and cited multiple drug compounding and GMP violations. For example, it failed to establish an
FDA Policy/General
FDA commissioner Stephen Hahn says that over the past year the agency has seen about 1,000 net growth in staff due to a streamlined hiring spree authorized by the recent CURES Act. “For FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net
FDA Policy/General
Oncologic Panel to Review GSK Myeloma BLA Federal Register notice: FDA announces a 12/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BLA for belantamab mafodotin, indicated for treating certain adults with relapsed or refractory multiple myeloma. 11/13/2020 Notice Corrected on ANDAs Withdrawn
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
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
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
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
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
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.
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 7/15 notice about a draft guidance #61 entitled Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species. FDA is taking this action in response to a request
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Insanitary Conditions at Compounding Facilities. The document is intended to help compounding facilities and state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious