FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Labeling for Biosimilar Products.” The document provides recommendations on the prescribing information (package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). It also provides an overview
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Use of Electronic Health Record (EHR) Data in Clinical Investigations.” The document is intended to facilitate the use of EHR data in clinical investigations and to promote the interoperability of EHR and electronic data capture systems. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions.” The document provides recommendations for information and testing that should be included in 510(k) submissions for such devices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The document describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling alone is not sufficient
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher for a rare pediatric disease product application — GW Research Ltd.’s Epidiolex(cannabidiol oral solution). The product is indicated for treating seizures associated with Dravet Syndrome or Lennox-Gastaut Syndrome in patients two years of age and older. To view
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Baxter (Claris Injectables Ltd.) Gujarat, India (7/5): FDA inspected the firm 8/2017 and cited significant GMP violations for finished pharmaceuticals. The firm invalidated out-of-specification results
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Science Board for an additional two years. The new charter will be in effect until 6/26/2020. To view the notice, click here.
FDA Policy/General
FDA has published a report summarizing the major points explored with stakeholders at a 4/16 public workshop on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The report says the workshop “provided an opportunity for representatives from academia, industry, healthcare delivery, government, and patient advocacy groups to discuss a
EIRs/483s
FDA has extended by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the risk of major adverse cardiovascular events in adults with Type 2 diabetes who have established cardiovascular disease or are at risk for the disease. The submission also applies
FDA Policy/General
Federal Register notice: FDA has submitted for OMB clearance an information collection extension for “New Animal Drugs for Investigational Use” (OMB Control Number 0910–0117). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Hypertension: Conducting Studies of Drugs Treat Patients on a Background of Multiple Antihypertensive Drugs.” The document was developed based on sponsors’ interest in developing drugs intended to treat resistant hypertension, which sponsors have defined as hypertension not adequately controlled
FDA Policy/General
Federal Register notice: FDA has submitted for OMB clearance an information collection extension for “Petition To Request an Exemption From 100% Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR 111.75(a)(1)(ii)” (OMB Control Number
FDA Policy/General
Federal Register notice: FDA has announced a 9/27-28 “Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery — Influences of Sex and Gender.” The conference is intended to discuss the biological (sex) and sociological (gender) influences on misuse, abuse, and cessation of opioids and tobacco. To view the notice,
FDA Policy/General
Federal Register notice: FDA has submitted for OMB clearance an information collection entitled “Guidance for Industry on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.” To view the notice, click here.
FDA Policy/General
Draft Guide on Rare Disease Gene Therapies Federal Register notice: FDA makes available a draft document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” 07/12/2018 Guide on CMC Info for Gene Therapy Products Federal Register notice: FDA makes available a draft guidance entitled “Chemistry, Manufacturing,
FDA Policy/General
American Diversified Holdings has acquired Houston-based Brazos Biomedical. The transaction gives American Diversified the AURACIS TENS Migraine therapy system, including all patents and patent applications in the U.S. and abroad, patent license agreements, technical engineering schematics, FDA plans, patient study information and other related assets. LabCorp has acquired
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” The document provides recommendations on the clinical trial design and related development of coagulation Factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in
FDA Policy/General
Federal Register notice: FDA has made available a draft document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” The document provides recommendations on designing clinical development programs for such products where there may be limited study population size and potential feasibility and safety issues, as well as
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).” The document provides sponsors of a human gene therapy IND with recommendations about CMC information required to assure product safety, identity, quality, purity, and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” The document provides recommendations related to product development, preclinical testing, and clinical trial design for such products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products” (OMB Control Number 0910-0429). The guidance was issued to help individuals with procedures on formal meetings between FDA and sponsors
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” The document is intended to assist sponsors in all phases for developing antiviral drugs for treating or preventing smallpox. It revises a 2007 draft guidance similarly named. To view