EIRs/483s
FDA has approved a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. Patients with ESRD rely on AV fistulae for hemodialysis, and over time vessel restenosis limits
FDA Policy/General
Federal Register notice: FDA has established a public docket for interested parties to nominate bulk drug substances or re-nominate bulk drug substances that were previously nominated without adequate supporting information for inclusion on a list of bulk drug substances for compounding certain animal drugs without a patient specific prescription
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for Industry #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The document describes FDA’s current thinking about compounding animal drugs from bulk drug substances. The agency has generally exercised enforcement discretion on animal drug compounding from bulk drug
FDA Policy/General
FDA commissioner nominee Stephen Hahn sailed through his Senate confirmation hearing 11/20 with praise and some resistance from lawmakers. Senate Health, Education, Labor & Pensions chair Lamar Alexander (R-TN) called Hahn an “impressive choice” to lead FDA. “This is a critical time for FDA, and there is a
FDA Policy/General
Federal Register notice: FDA has announced a 12/13 Dermatologic and Ophthalmic Drugs Advisory Committee meeting. Panel members will discuss a Horizon Pharma Ireland BLA for teprotumumab solution for intravenous use to treat active thyroid eye disease. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 1/16 Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members will discuss a Durect NDA for bupivacaine extended-release solution for instillation for treating post-surgical analgesia. To view the notice, click here.
Drugs
In a recent CDER Webinar, Office of Prescription Drug Promotion lead project manager Jason Cober reviewed various types of errors the agency is seeing in promotional submissions in eCTD (electronic common technical document) format. A final guidance on eCTD submission of promotional labeling and advertising materials was issued 6/24.
FDA Policy/General
President Donald Trump apparently is pulling back administration plans to issue new rules on e-cigarettes/vaping to curb youth access. After a 9/11 White House meeting between then-FDA acting commissioner Ned Sharpless, HHS secretary Alex Azar and President Donald Trump, the agency was reportedly moving forward to
FDA Policy/General
Federal Register notice: FDA has announced a 12/5 public meeting entitled “2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.” The meeting is intended to help ensure that the clinical outcome assessments (COAs) and endpoints developed reflect what is most important to patients
FDA Policy/General
FDA has issued a draft guidance, Compounding Animal Drugs from Bulk Drug Substances, to describe agency policy on the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or licensed pharmacists. The document says FDA has generally exercised enforcement discretion with regard 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. A.P. Deauville, New Brunswick, NJ (11/8): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, it failed to thoroughly investigate
Drugs
FDA has sent Nascent Biotech an untitled letter objecting to promotional content on the company’s Web site about its investigational drug pritumumab. The letter says that discussing the drug’s safety and effectiveness for the purpose for which it is being investigated misbrands the product. FDA says the Web
FDA Policy/General
Federal Register notice: FDA has withdrawn ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis Laboratories. The drug products are both transdermal systems designed with a liquid reservoir. The companies have both requested withdrawal of their respective applications and have waived their opportunity for a
FDA Policy/General
Proposal to Withdraw 4 NDAs Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required annual reports. 11/15/2019 OTC Drugs Panel Charter Renewal Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory
FDA Policy/General
StemCutis, LLC says the Naval Medical Center San Diego has been added as a second site for the Phase 2 portion of its clinical trial for subjects with cutaneous photoaging, a skin condition caused by chronic ultraviolet radiation sun exposure. According to the company, the clinical trial combines low-dose
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required annual reports. The NDAs are: * NDA 014217 Maolate (chlorphenesin carbamate) tablets, 400mg (Pan American Laboratories) * NDA 018663 Chymodiactin (chymopapain) for Injection, 4,000 Units/vial and
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Nonprescription Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Q-Submission Program for Medical Devices” (OMB Control Number 0910-0756). The collection concerns a guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” and provides an overview of the mechanisms
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Testing Communications on Medical Devices and Radiation-Emitting Products” (OMB Control Number 0910-0678). Agency regulations permit it to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.” The document describes the information that the agency will provide to a person whose request for a Certificate to Foreign Government for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Hypertension Indication: Drug Labeling For Cardiovascular Outcome Claims” (OMB Control Number 0910-0670). The guidance encourages the submission of supplemental labeling and is intended to assist applicants in developing labeling for outcome claims for such drugs. To
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820” (OMB Control Number 0910-0073). This regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies