FDA Policy/General
Federal Register notice: FDA has issued a guidance entitled Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway to assist applicants in developing the Indications and Usage section of labeling for products approved under the accelerated approval regulatory pathway. The document focuses on indications
FDA Policy/General
Federal Register notice: FDA has determined that Genentech’s Esbriet (pirfenidone) film coated tablets (534 mg) was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met. Esbriet is indicated for
Drugs
FDA last year approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications, and four biosimilar applications in oncology. “These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and
Drugs
Genus Lifesciences has petitioned FDA to refuse to accept any submissions by Lannett Company for its 505(b)(2) application for cocaine hydrochloride 4% and 10%. A Genus 2/1 petition says the Lannett submissions are barred by the new chemical entity (NCE) exclusivity arising from FDA approval of the
Drugs
FDA says that Lymol Medical missed a milestone final report due date in the timetable for completion of a postmarketing requirement for sterile talc powder under its NDA. A 1/8 Warning Letter says the failure to comply without demonstrating a good cause for noncompliance violates the law and misbrands
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of ANDA #061579 for nonsterile neomycin sulfate powder for prescription compounding. The basis for withdrawal is that the product is no longer considered safe as labeled due to clinical evidence that systemic exposure to neomycin sulfate can induce significant toxicity, including ototoxicity (manifested
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Zhongbo Industrial Co., Zhejiang, China (11/27/2018): FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. The company failed to have, for
Devices
FDA has classified as Class 1 an Edwards Lifesciences recall of its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured between 12/26/2017 and 4/19/2018. An FDA notice says the recall is due to incorrect assembly and reversal of the catheter tubes (lumens). “If the
Drugs
FDA has issued Alkermes a complete response letter on its NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder. The agency letter requests additional clinical data to provide substantial evidence of the therapy’s effectiveness, according to the company. Alkermes says it plans to meet with FDA
FDA Policy/General
Federal Register notice: FDA has issued a draft guidance, ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs. The document says it provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on
Devices
FDA has classified as Class 1 a Smiths Medical recall of its sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) from damage to the containers used to package the finished products. Product use in patients could result
Devices
FDA has published a final guidance entitled The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles, as required by Congress in the FDA Modernization Act of 1997 for medical device premarket
Drugs
Generic drugs lobbying arm Association for Accessible Medicines (AAM) says it is concerned that new legislation introduced by Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) may have the “unintended impact of reducing competition in the prescription drug market and thus lead to patients continuing to pay
FDA Policy/General
Federal Register notice: FDA has released a draft International Council for Harmonization guidance, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines, recommending international standards for nonclinical safety studies recommended to support development of pediatric medicines. The document recommends an approach for the nonclinical safety evaluation of medicines
Drugs
FDA says it is evaluating recent interim post-approval study (PAS) results which suggest a higher mortality rate for patients treated with Abiomed’s Impella RP System than the rate previously observed in premarket clinical studies. The Impella RP System is a temporary right heart pump system intended to help
Devices
Federal Register notice: FDA has posted a guidance on Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection that provides recommendations to facilitate industry development and validation of assays for assessing the immunogenicity of such products during clinical trials. The document includes guidance on
FDA Policy/General
Rare Disease Drug Development Guide Federal Register notice: FDA issues a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in conducting more efficient and successful drug development programs. 02/01/2019 Guide on REMS Assessment: Planning and Reporting Federal Register notice: FDA makes
Drugs
DRUGS FDA has approved a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. The intravenous infusion is intended to be administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-
Biologics
After 16 years at FDA, CDER Therapeutic Biologics and Biosimilars Staff director Leah Christl is leaving to pursue other opportunities, effective 2/22. She joined FDA in 2003 as a regulatory project manager in the Over-the-Counter Drug Products Division. She later served as associate director for regulatory affairs
FDA Policy/General
Federal Register notice: FDA has issued a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in conducting more efficient and successful drug development programs. The document revises and replaces an 8/2015 drug guidance by updating the natural history studies section; inclusion of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled REMS Assessment: Planning and Reporting. The document describes how to develop a risk evaluation and mitigation strategy (REMS) assessment plan, specifically how the REMS program goals, objectives, and REMS design may affect the selection of metrics and data sources,
Devices
Terrific Care/Medex Supply has recalled all lots of Roche Diagnostics’ CoaguChek XS PT Test Strips that were manufactured 10/2017 to 5/2018 due to inaccurate International Normalized Ratio test results, when compared to laboratory results. The test strips may provide results that are higher than the actual INR,