FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Gene Therapy for Rare Diseases; Guidance for Industry.” The document provides information to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members, excluding consumer representatives, to serve on CDRHֺ’s Patient Engagement Advisory Committee. Nominations are being accepted for current and upcoming vacancies. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published a list of 16 information collections approved by OMB. They are: * Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States * Postmarket Surveillance of Medical Devices * Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed study entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The study intends to examine four types of endorsers (celebrity, physician, patient, social media influencer) and whether the presence of a disclosure of their payment status influences
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use — Premarket Notification (510(k)) Submissions.” The document outlines device design considerations, risk mitigation strategies, and testing recommendations for such devices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed “Study of Oncology Indications in Direct-to-Consumer Television Advertising.” The study objective is to determine whether disclosing information about the nature of endpoints that support the indications for oncology products helps consumers understand a drug's efficacy. To
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Baja Fur City of Industry, CA (12/13): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of a new animal drug application and two abbreviated new animal drug applications at the sponsors’ request because they are no longer manufactured or marketed. The products are Fleming Laboratories’ NADA for Wazine (dipiperazine sulfate and piperazine HCl); Halocarbon Products ANADA for halothane;
FDA Policy/General
Federal Register notice: FDA has extended until 3/19 the comment period for its draft guidance on “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials.
Drugs
FDA is seeking comments on two proposed studies entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The agency intends to examine four types of endorsers in the studies (celebrity, physician, patient, and social media influencer) and it will examine whether the presence of a disclosure of
FDA Policy/General
Federal Register notice: FDA has made available two final guidances entitled “Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions” and “In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.” The guidances are intended to assist drug developers in evaluating drug-drug interaction
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys 53 (golodirsen) for treating Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. To view
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Draft Guidance for Levonorgestrel.” The document provides product-specific recommendations on bioequivalence studies to support ANDAs for a levonorgestrel intrauterine device. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 2/26 Oncologic Drugs Advisory Committee meeting. During the morning session, the panel will discuss a Steba Biotech NDA for padeliporfin di-potassium powder for solution for treating patients with localized prostate cancer. In the afternoon, they will discuss an Eli Lilly supplemental
FDA Policy/General
ABH Nature's Products, ABH Pharma and Stocknutra.com is conducting a nationwide recall of its dietary supplement products manufactured and sold between 1/2013 to 11/2019. The products are being recalled after an FDA inspection found significant GMP violations, according to a recall notice. To date, it
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Reporting Associated With Animal Drug and Animal Generic Drug User Fees” (OMB Control Numbers 0910-0540). The information is used by CVM to initiate the administrative screening of new animal drug applications and supplements. To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Products — 21 CFR Parts 1000 Through 1050” (OMB Control Number 0910-0025). FDA has the authority to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards
FDA Policy/General
Federal Register notice: FDA has determined that Chiesi USA’s Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for nicardipine hydrochloride injection if all other legal and regulatory requirements are met. Cardene
FDA Policy/General
Federal Register notice: FDA has classified radiological computer-aided triage and notification software into Class 2 (special controls). The classification was made based on a de novo request by Vizai for its ContaCT device. FDA has identified the product as an image processing device intended to aid in prioritization and
FDA Policy/General
Federal Register notice: FDA has classified the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into Class 2 (special controls). The classification was made after Quantitative Insights submitted a de novo request for its QuantX device. FDA identified the product as an image processing device intended to
FDA Policy/General
Federal Register notice: FDA has issued an order to reclassify medical image analyzers, including CADe devices, for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection from Class 3 to Class 2 (special controls). The order assigns such devices the generic name medical image analyzer,