FDA Policy/General
Federal Register Final Rule: FDA has amended its nonprescription (over-the-counter or OTC) drug regulations to supplement the time and extent application (TEA) process by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act. It also amends the
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Nonprescription Sunscreen Drug Products — Format and Content of Data Submissions.” The document provides FDA’s current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data.” The document addresses the agency’s thinking about data needed to determine whether a nonprescription over-the-counter sunscreen ingredient or combination of ingredients evaluated under the Sunscreen Innovation Act is generally
FDA Policy/General
President-elect Donald Trump met with Indiana state health commissioner Jerome Adams on 11/21, presumably as a candidate for HHS secretary or another health-related position in the new administration. They discussed establishing better doctor–patient relationships, healthcare challenges Americans face each day with Obamacare, and ideas for enacting
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Medtronic’s Core Valve System for patent extension purposes — 1,194 days. Of this time, 1,017 days occurred during the testing phase of the regulatory review period, while 177 days occurred during the approval phase. To view the
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Pharming Group’s Ruconest for patent extension purposes — 3,502 days. Of this time, 3,045 days occurred during the testing phase of the regulatory review period, while 457 days occurred during the approval phase. To view the notice,
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Celgene’s Cerdelga (eliglustat) for patent extension purposes — 3,854 days. Of this time, 3,520 days occurred during the testing phase of the regulatory review period, while 334 days occurred during the approval phase.
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization draft is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. NutriResearch, Inc. Kent, WA (11/15): FDA reviewed the firm’s Web site and determined that claims on its product labels and pamphlets establish that the dietary supplements are
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates.” The document provides establishments that make eligibility determinations for donors of human cells, tissues, and
FDA Policy/General
Federal Register Notice: FDA has made available a report on a CVM working group that proposes possible changes to the current review processes for new animal drug applications containing multiple new animal drugs in combination drug medicated feeds. The report was developed for a CVM committee that will be participating
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.” The document provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of
FDA Policy/General
DEVICES Comments Sought on Radiation Product Requirements Federal Register Notice: FDA is seeking comments on an OMB submission to extend an information collection on reporting and recordkeeping requirements for manufacturers and distributors of electronic products. The requirements are outlined under the agency’s electronic product radiation control program, including the
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension on medical device premarket notifications. The collection is related to Section 510(k) that requires a premarket notification submission to FDA at least 90 days before the introduction into interstate commerce of a device intended for human use.
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension on its “Guidance for Industry on Special Protocol Assessment” that describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance also describes procedures for sponsors to request
FDA Policy/General
Federal Register Final Rule: FDA is amending its current good manufacturing practice and labeling regulations regarding medical gases to require that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the
FDA Policy/General
Federal Register Notice: FDA has announced the availability of a guidance entitled “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.” The document provides a detailed description of the information that should be included in a premarket notification for such devices. To view the guidance, click here. To view the
FDA Policy/General
Federal Register notice: FDA has determined that the drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw ANDAs that reference the products, and it will allow FDA to continue to approve
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Bacillus Calmette-Guerin (BCG) — Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.” The document is intended to assist sponsors in developing drugs and biologics to treat patients with a high-risk form of bladder cancer. It
FDA Policy/General
Federal Register Notice: FDA has announced a 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. Pharmaceutical companies are invited to participate, and should submit a site visit proposal to OPQ by 1/17/2017. To view the notice, click here.
FDA Policy/General
Regulatory consulting firm Greenleaf Health has brought on two former senior FDA officials — former Office of Regional Operations director David Elder and former CDRH associate director for regulations and policy Kate Cook. At Greenleaf, Elder joins the firm’s Product Quality, Manufacturing & Compliance group, where he will provide “strategic
FDA Policy/General
FDA may be on cruise control until president-elect Donald Trump takes office in January. On 11/15, House Republican leaders wrote FDA commissioner Robert Califf and other federal agency heads to caution them against finalizing pending rules or regulations until after Trump is sworn in. “By refraining from acting