FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “E6(R3) Guideline for Good Clinical Practice.” The agency says the International Council for Harmonization document outlines modernized good clinical practice considerations for designing and conducting clinical trials in a manner that ensures participant safety and the reliability of
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of an emergency use authorization issued to B. Braun Melsungen AG for propofol-lipuro 1% injectable emulsion. The company notified the agency that the product’s inventory has been depleted and that it does not intend to offer this product in the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” The document is intended to assist ANDA sponsors with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, and amendments and supplements. To
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Vintage Pharmaceuticals ANDA for pemoline tablets in response to the sponsor’s request. All pemoline product sponsors stopped marketing their products in 2005 due to an FDA safety alert that concluded the overall liver toxicity risk of Cylert (pemoline) and associated
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Krystal Biotech in response to an approved rare pediatric disease product application. The qualifying product is Vyjuvek (beremagene geperpavec-svdt) for treating patients six months of age or older with dystrophic epidermolysis bullosa. To view the
FDA Policy/General
FDA is experiencing a larger-than-normal exodus of retiring employees now that the Covid-19 public health emergency is winding down. Speaking at an Alliance for a Stronger FDA virtual staffing update 6/5, FDA chief of staff Julie Tierney said that so far in fiscal year 2023 there
FDA Policy/General
FDA has released a final guidance entitled “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” Focused on nonclinical safety evaluations by sponsors, it defines immunotoxicity as “any adverse unintended immunosuppression or stimulation, which can be the result of off-target effects or exaggerated pharmacology of pharmaceuticals that are intended to
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Drug-Drug Interaction (DDI) Assessment for Therapeutic Proteins.” The document is intended to help stakeholders determine the need for DDI studies for a therapeutic protein using a systematic, risk-based approach. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.” The document includes recommendations for drug development programs for drugs intended to treat patients with the syndrome. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Migraine: Developing Drugs for Preventive Treatment.” The document focuses on specific drug development and trial design issues that are unique to drugs being developed for preventing migraines. To view the notice, click here.
FDA Policy/General
After serving at FDA for eight years, CDER Office of New Drug Policy director Maarika Kimbrell has left the agency to re-enter private legal practice at Morgan Lewis as a partner resident to counsel pharma/biotech companies on regulatory matters. Previously at FDA, she served as deputy chief of
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of eight ANDAs from multiple applicants after they informed the agency that the products were no longer marketed and requested they be withdrawn. The withdrawn products are: * Hospira’s metoprolol tartrate injectable, * Tolmar’s calcipotriene solution * American Regent’s dorzolamide HCl solution/drops
FDA Policy/General
Federal Register notice: FDA is announcing that it intends to inactivate the registration of establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) that have not updated their annual registration under the agency’s electronic human cell and tissue establishment registration system. Agency regulations require
FDA Policy/General
FDA and the European Union have agreed to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals. Under the expanded MRA, FDA can rely on GMP inspections of veterinary product facilities conducted by
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” The document provides recommendations to assist manufacturers in complying with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.” The document provides recommendations for demonstrating efficacy for drugs that are intended to reduce diabetes-related hyperglycemia (i.e., antihyperglycemic drugs) and to mitigate iatrogenic hypoglycemia
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” The document discusses general recommendations for performing covariate adjustment using linear models, and for performing covariate adjusting using nonlinear models. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that a Fresenius Kabi NDA for heparin sodium injection was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Heparin sodium Injection is an anticoagulant
FDA Policy/General
Federal Register notice: FDA has determined that Purdue Pharma’s Chirocaine (levobupivacaine) injection (multiple strengths) was not withdrawn due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.” The document is intended to assist sponsors in determining when it may be appropriate to rely on generally accepted scientific knowledge to fulfill certain legal and
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers.” The question-and-answer document is intended to clarify FDA’s recommendations on managing, documenting and using whole slide images in histopathology assessments and pathology peer review
FDA Policy/General
Federal Register notice: FDA is announcing a 6/28 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Ipsen Biopharmaceuticals NDA for palovarotene capsules, indicated for preventing heterotopic ossification in adults and children (females aged eight years and above and males 10 years and above)