FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document highlights criteria for submitting applications under the abbreviated approval pathways described in Section 505(j) and 505(b)(2), identifies considerations to help potential applicants determine
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” The document discusses the conduct of in vivo absorption trials for topically applied active ingredients that are
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” The document is mainly focused on reproductive toxicity (embryo-fetal development), and it provides recommendations to applicants for pharmaceutical labeling on duration of contraception following therapy cessation to minimize potential risk
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.” The document provides instructions on how to document that a submission includes real-world evidence. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Postapproval Pregnancy Safety Studies” that provides recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Lactation Studies: Considerations for Study Design.” The document provides the agency’s current recommendations to sponsors about such studies during drug development. The studies are intended to provide information and data for completing the lactation subsection in a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Experimental Study of an Accelerated Approval Disclosure.” The study is intended to examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer promotional materials. This
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities.” The federal Food, Drug, and Cosmetic Act requires FDA to develop a list of bulk drug substances that may be used in compounding.
FDA Policy/General
The HHS Centers for Medicare and Medicaid Services has finalized a rule requiring direct-to-consumer TV ads for prescription drugs covered by Medicare or Medicaid to include the list price — defined in the rule as the wholesale acquisition cost — if that price is equal to or greater than $35
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Utilizing Animal Studies to Evaluate Organ Preservation Devices.” The document recommends balancing the ethical principles of replacement, reduction, and refinement as well as regulatory least burdensome principles, with the goal of using the minimum number of animals necessary to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy Clarification for Certain Fluoroscopic Equipment Requirements.” The document is intended to clarify FDA’s interpretation of certain aspects of the performance standard requirements for fluoroscopic equipment. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).” The document describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission standards during laser product classification under the Electronic Product
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Laser Products — Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1(Laser Notice No. 56).” The document is intended to describe the agency’s approach to compliance with FDA’s performance standards for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Medical X-Ray Imaging Devices Conformance with IEC Standards.” The document describes FDA’s policy on the regulation of medical x-ray imaging equipment that is subject to the agency’s medical device and electronic product regulations. To view
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is proposing to research the presence, wording, and prominence of a disclosure communicating information related to a drug’s accelerated approval in direct-to-consumer promotional materials. A 5/8 Federal Register notice says FDA requires that the Indications and Usage section
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: Laboratoires Clarins, Pontoise, France (4/23): FDA inspected the firm 9/2018 and cited significant GMP violations with finished pharmaceuticals. For example,
FDA Policy/General
Federal Register notice: FDA has announced a 6/20 meeting of the Oncologic Drugs Advisory Committee’s Pediatric Oncology Subcommittee. During the morning session, panel members will review and discuss two pediatric molecular targets: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for Treatment.” The document is intended to assist sponsors in the clinical development of stimulant drugs for treating ADHD in pediatric and adult patients. It also addresses the agency’s current
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/18/2021. To view the notice, click here.
FDA Policy/General
Priority Voucher Redeemed for Alexion’s Ultomiris Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher — Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz). 05/03/2019 Update to Susceptibility Test Interpretive Criteria Page Federal Register notice: FDA has made available its annual compilation of updates to
FDA Policy/General
DEVICES AliveCor has received FDA 510(k) clearance for its Heart Monitor, a mobile ECG device, compatible with the iPhone 4 and 4S models, that enables doctors to evaluate patient heart health remotely. Ethicon Biosurgery has received FDA approval for the Evarrest Fibrin Sealant Patch, intended for use as an