FDA Policy/General
Federal Register notice: FDA has extended until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription laxative polyethylene glycol 3350. In April, FDA received petitions for a stay on behalf of four ANDA holders: Breckenridge Pharmaceutical and Nexgen Pharma, who submitted a joint petition;
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 31 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that their approvals be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: CDRH has announced its 2019 Experiential Learning Program, which is intended to provide the Center and other agency staff with an opportunity to understand laboratory practices, quality system management, patient perspective/input, and challenges that impact the medical device development life cycle. This notice invites the device
FDA Policy/General
Draft Guide on Rare Diseases with Substrate Deposition Federal Register notice: FDA makes available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” 07/27/2018 Guide on Certain Pediatric Orphan
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” The document applies only to diseases with a well-characterized pathophysiology and in which changes
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” The agency says it does not expect to grant any additional orphan-drug designations to drugs for pediatric subpopulations of common diseases (i.e., diseases
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2019 rates for generic drug program areas. For FY 2019, rates are: ANDA ($178,799), Drug Master File ($55,013), domestic Active Pharmaceutical Ingredient (API) facility ($44,226), foreign API facility ($59,226), domestic Finished Dosage Form (FDF) facility ($211,305)
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification [510(k)] Submissions.” The guidance encourages industry to engage CDRH under its pre-submission process to obtain feedback based on device indications and operational characteristics. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that metaxalone tablets, 640 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The determination was made in response to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products — 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82” (OMB Control Number 0910-0759). FDA regulations require manufacturers to provide notice of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.’’ The document applies to orally administered drug products and provides recommendations to sponsors who will
FDA Policy/General
Federal Register notice: FDA has announced a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketplace, including greater availability of biosimilar and interchangeable products. The agency is interested in feedback on the following topics, among others: * Provide additional scientific or regulatory clarity
FDA Policy/General
Federal Register notice: FDA has announced a 9/12 Pharmacy Compounding Advisory Committee meeting. Panel members will receive information on balancing the criteria for 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion
FDA Policy/General
Federal Register notice: FDA has announced an 8/21 public workshop entitled “Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.” The workshop is intended to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight
FDA Policy/General
FDA is launching a new public campaign focused on “recruiting skilled and dedicated employees who want to help FDA advance its public health mission.” The campaign includes print ads at rail stations, in rail cars, and on buses in the D.C. area. The campaign uses a new graphic and
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Lee Silsby Compounding Pharmacy Cleveland Heights, OH (7/10): FDA inspected the firm 6/2017 and found that it was not adhering
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes the agency’s current recommendations on this subject where dietary management is a key component
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
FDA Policy/General
DEVICES FDA has cleared an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use in treating cancer. The software allows practitioners 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy)
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for its “Metered Dose Inhaler and Dry Powder Inhaler Drug Products — Quality Considerations; Draft Guidance for Industry.” Comments can be submitted by 9/18. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is extending the comment period until 10/18 for a guidance entitled “Documenting Electronic Data Files and Statistical Analysis Programs.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” (OMB Control Number 0910–0572). FDA’s regulations require that the labeling of new and recently approved products contain highlights of prescribing information,