FDA Policy/General
Federal Register notice: FDA has announced a 9/27 Neurological Devices Panel meeting to review a Sequent Medical PMA for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in
FDA Policy/General
Quality Metrics Proposal Period Extended Federal Register notice: FDA extends the proposal period for its “Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff” to allow interested persons additional time to submit a proposal. 08/17/2018 Info Collection
FDA Policy/General
Federal Register notice: FDA has extended the proposal period for its “Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff” to allow interested persons additional time to submit a proposal. Proposals are being accepted until 12/17. To view
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has granted an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. The Voluntary Malfunction Summary Reporting Program is mandated by the recent device user fee reauthorization agreement to streamline malfunction reporting. To view the
FDA Policy/General
Federal Register notice: FDA has identified a list of device accessories for which it believes general controls are sufficient to provide reasonable assurance of safety and effectiveness. The notice proposes to classify the accessories into Class 1, and it seeks comments on the actions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/17 workshop entitled “Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cure Diseases in Humans.” The workshop will exchange information with the scientific community about the clinical, manufacturing, and regulatory considerations associated with live microbiome-based products.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI).” As part PDUFA VI, FDA committed
FDA Policy/General
A 2018 Center for Science and Democracy (CSD) survey of FDA scientists highlighted issues regarding the agency’s science-based decision-making processes, including evidence of the improper influence of political leadership, constraints resulting from workforce reductions, and limited resources for professional development. CSD surveyed more than 63,000 federal
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Ultragenyx Pharmaceutical for its approved rare pediatric disease product application. The product, Crysvita (burosamab-twza), is indicated for treating X-linked hypophosphatemia in adult and pediatric patients one year of age and older. To view the
FDA Policy/General
FDA says it is overcoming the lack of acute and chronic pain management information specifically tailored to veterinary medicine with issuance of a new resource with information and recommendations for veterinarians who stock and administer opioids. The intent, according to a statement from FDA commissioner Scott Gottlieb, is to ensure
FDA Policy/General
Federal Register notice: FDA has announced a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. Panel members will discuss modernizing drug application assessments through a Knowledge-Aided Assessment and Structured Application initiative. Additionally, they will discuss in-vitro/in-vivo relationship standards, and establishing patient-focused dissolution standards
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of 20 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection request entitled “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The agency plans to investigate, through empirical research, various combinations of the “important safety information” and brief summary sections in DTC ads.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Apotex Research Private Ltd. Bangalore, India (8/9): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” The document discusses study designs that employ multiple, concurrently accruing, patient cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics,
FDA Policy/General
Federal Register notice: FDA has announced a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to identify what is most important to patients and caregivers with respect to disease burdens, treatment burdens, and the benefits and risks in managing a patient’s
Drugs
FDA has proposed a new “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads” that is intended to research regulatory requirements for fair balance and the brief summary. Specifically, the agency wants to know if repeating warnings in the Important Safety Information (ISI) section
FDA Policy/General
Workshop on Human Skin Safety Testing for Topicals Federal Register notice: FDA announces a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.” 08/10/2018 FDA Proposes New Drug Promotion Study on Disclosures Federal Register notice: FDA submits to OMB
FDA Policy/General
Federal Register notice: FDA has announced a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.” The workshop is intended to provide a forum to discuss the current state and future directions of the collection of human data on potential skin
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection study entitled “Disclosures in Professional and Consumer Prescription Drug Promotion” (OMB Control Number 0910-New). The proposed research will examine the effectiveness of clear and conspicuous disclosures in prescription drug promotion directed to both healthcare professionals and consumers.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.” The document describes when a standard release test and criteria may be used in lieu of extensive method development and acceptance