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Federal Register Notice: FDA has made available a draft guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.”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
Drugs
A 12/14-12/18/15 FDA inspection at Srikem Laboratories, Mumbai, India, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to an 11/8 Warning Letter. Specific deviations included: * failing to have laboratory control records that include complete data derived from all laboratory
Drugs
FDA has issued two guidances in partial fulfillment of requirements under the 2014 Sunscreen Innovation Act. The first guidance, Nonprescription Sunscreen Drug Products—Safety and Effectiveness Data, addresses the agency’s thinking about data needed to determine whether a nonprescription over-the-counter sunscreen ingredient or combination of ingredients evaluated
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
Drugs
Attorneys Joanne Hawana and Benjamin Zegarelli (Mintz Levin) say that five recurring themes arose from a recent two-day FDA hearing on the appropriate regulatory approach to manufacturers’ communications about off-label uses for their marketed products. Writing in an online blog post, they summarize the themes as: * Use different
Drugs
A 10/5-10/13/15 FDA inspection at CP Pharmaceuticals, Wrexham, UK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/16 Warning Letter. Specific violations included: * failing to follow appropriate written procedures designed to prevent microbiological contamination of drug products
Drugs
FDA has posted a guidance on “Safety Testing of Drug Metabolites” that provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. “The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are
Drugs
The International Probiotics Association has petitioned FDA asking that it amend its regulations to require the quantitative amount of probiotic ingredients in a dietary supplement to be presented in terms of colony forming units (CFUs) instead of by weight. “The amendment to the regulations requested here would help ensure that
Drugs
FDA has sent Antera Therapeutics an untitled letter due to promotional claims on the company’s Web site that make Aralyte Starter Kit an unapproved biological product. Aralyte is described as an all natural peanut protein formula. Claims on the Web site demonstrate that the product is intended to prevent
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
Drugs
Sanofi Pasteur has decided to discontinue making TheraCys (BCG live attenuated), indicated for treating non-muscle invasive bladder cancer. In an email sent to urologists late last week and obtained by Forbes contributor Benjamin Davies, the company notes how it brought the product back online after resolving GMP issues at
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
Devices
FDA has been encouraging medical device sponsors to conduct more early feasibility studies (EFS) in the U.S., and it is now suggesting approaches to improving the process based on the agency’s experience with the process. Writing in a recent Journal of the American College of Cardiology article, agency
Drugs
Cantrell Drug Co. has recalled certain unexpired sterile drug products due to lack of sterility assurance. Affected products include calcium chloride, fentanyl citrate, glycopyrrolate, heparin sodium, and hydromorphone, among others. “Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may
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
Devices
FDA is delaying guidelines for regulating laboratory-developed tests until after the Trump Administration takes office in January. Earlier this year, Congressional Republicans (see story) balked at the agency’s plans to finalize guidelines, warning it not to overreach since a draft guidance was released in 2014. House Energy and