FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2018 public workshop entitled “Self-Collection Devices for Pap Test” that will obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and least burdensome validation approaches for self-collection devices for cervical samples for cervical cancer screening
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271.” The document provides establishments that manufacture such products with recommendations
FDA Policy/General
FDA deputy commissioner for policy, planning, legislation, and analysis Anna Abram says the agency is looking for feedback from many stakeholders as it reviews more than 4,000 pages of agency regulations in the Code of Federal Regulations to see how they can be modernized, revised, updated, or eliminated. Writing
FDA Policy/General
Federal Register notice: FDA has announced a 10/30 public workshop entitled “CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development” that is intended to help the rare disease community to understand what the agency needs to enhance drug development. It
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The document is intended to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use
FDA Policy/General
Federal Register notice: FDA has announced a 10/3 public meeting entitled “Development of a List of Pre-DSHEA Dietary Ingredients” that will give stakeholders an opportunity to discuss issues related the agency’s future development of such a list. The list is related to a 2016 draft guidance on
FDA Policy/General
Federal Register notice: FDA has determined that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs referencing the NDA if all other legal and regulatory requirements
FDA Policy/General
Federal Register notice: FDA has determined that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference Gynorest if all other legal and regulatory
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a Cipher Pharmaceuticals professional detail aid for ConZip (tramadol hydrochloride) extended-release capsules for oral use is false or misleading because it omits important risk information associated with using ConZip and other material facts. In an 8/24 Warning Letter,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.” This document is mandated under the FDA Safety and Innovation Act by requiring certain submissions be submitted in electronic format,
FDA Policy/General
Federal Register notice: FDA has created a public docket to collect comments related to pediatric post-marketing pharmacovigilance and drug utilization reviews of products posted between 3/11 and 9/12 on the agency’s Web site (see postings) but not presented at an upcoming 9/12 Pediatric Advisory Committee
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Research & Development’s Nizoral (ketoconazole) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that reference Nizoral, indicated for treating the following systemic fungal infections in patients
FDA Policy/General
Federal Register notice: FDA has announced the availability of a guidance entitled “Procedures for Meetings of the Medical Devices Advisory Committee.” The guidance is intended to provide additional information on the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel. It
FDA Policy/General
FDA has released a draft guidance on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies (REMS) Document Using Structured Product Labeling Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 9 379k-1(
FDA Policy/General
Federal Register notice: FDA has announced the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. The agency will continue to support of the newer SDTM Version 1.3 and Version 1.
FDA Policy/General
Federal Register notice: FDA has announced support for the most current version of the Medical Dictionary for Regulatory Activities (MedDRA), the end of support for earlier versions of MedDRA, and an update to the FDA Data Standards Catalog for study data provided in regulatory submissions. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has determined that Teva’s Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to approve
FDA Policy/General
Federal Register notice: FDA has made available a draft revised guidance for industry on generic digoxin tablets. The document, “Draft Guidance on Digoxin,” is intended to provide product- specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for digoxin tablets. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydrochloride extended-release capsules due to concerns about the validity of bioequivalence data submitted from studies conducted by an unnamed contract research organization. The agency notified the company in 2011. Subsequently, Upsher-
FDA Policy/General
FDA has released the FDA-483 issued following a 2/22-4/7/16 agency inspection at Wickliffe Pharmaceutical, a Lexington, KY, veterinary drug product producer. The document lists two inspection observations: * reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will conform with all established
FDA Policy/General
Federal Register notice: FDA has announced medical device user fee rates and payment procedures for fiscal year 2018. The rates are as follows: 510(k) $10,566; de novo classification $4,195; PMA/PDP/BLA $310,754; panel track supplement $233,073; 180-day supplement $46,615; annual report $10,
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2018 rates for generic drug user fees. Application fees are: ANDA ($171,823) and Drug Master File ($47,829). Facility fees are: domestic API facility ($45,367), foreign API facility ($60,367), domestic finished dosage facility ($211,087), foreign finished dosage facility