FDA Policy/General
Federal Register Notice: FDA will hold a public meeting 5/16 on the Animal Generic Drug User Fee Act (AGDUFA) from 1 p.m. to 4 p.m. at FDA, 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD. FDA invites public comment by 5/4 on the AGDUFA program
FDA Policy/General
Federal Register Notice: FDA plans a public meeting 5/16 from 9 a.m. to 12 p.m. at FDA, 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions on the features
Drugs
Pharmakon Pharmaceuticals has recalled all lots of its aseptically compounded sterile products due to FDA concerns over a lack of sterility assurance and other quality issues. “Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death,
Drugs
The National Institutes of Health (NIH) says that an evaluation by two consulting firms ordered in response to serious problems identified by FDA in the NIH Clinical Center Pharmaceutical Development Section has led to suspension of production in two facilities. The evaluation looked at all facilities producing sterile or infused
Devices
Medtronic says it is recalling the battery pack in Covidien Oridion-labeled patient monitors. The company says that the recall is due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. The packs were produced by a contract manufacturer between 4/2014
FDA Policy/General
Federal Register Notice: FDA is seeking comments on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. Comments should be submitted by 6/20. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information. This document is a revised version of a draft guidance that published in 2/2003 entitled “Comparability Protocols: Chemistry, Manufacturing, and Controls Information.” A related
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. It provides industry and agency staff with suggestions on how to best characterize the technical aspects that are relevant to whole slide imaging performance for their intended use and determine
FDA Policy/General
Federal Register Notice: FDA is making available guidance for industry entitled Distributor Labeling for New Animal Drugs. It discusses FDA’s current thinking on the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as
Drugs
FDA has lifted a clinical hold on a Cara Therapeutics adaptive pivotal trial of intravenous (IV) CR845 for postoperative pain. “A protocol-specified stopping rule, based on elevated serum sodium levels greater than 150 mmol/L, was met during the first phase of the study, and a review of unblinded
FDA Policy/General
Federal Register Notice: FDA is requesting that public stakeholders notify the agency of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires 9/30/18. The FD&C Act requires that FDA consult
FDA Policy/General
Federal Register Notice: FDA is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires 9/30/18. To view this notice, click here.
Drugs
FDA has released safety labeling changes 35 drugs that were approved 3/2016, including a Contraindication for hypersensitivity in Janssen’s Invega (paliperidone) extended-release tablets and extended-release injectable suspension, Janssen’s Invega Trinza (peliperidone/palmitate) extended-release injectable suspension, and Janssen’s Risperdal (risperidone) tablets, oral solution, and
Devices
Rep. Michael Fitzpatrick (R-PA) says that he has information showing a “dramatic change in how adverse event reports relating to the permanent sterilization device Essure were submitted to FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.” In a 4/19 letter
Devices
FDA has issued a guidance, Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device, with recommendations for the technical assessment performance data to be provided for regulatory evaluation of a digital whole slide imaging system. The document does not cover the clinical submission data that may be necessary to
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the links following each letter. Advanced Vision Science Inc. Goleta, CA (4/6). Inspected 7/27-8/3/15. QSR deviations, adulterated: The firm’s complaint handling procedure lacks detail as to how complaints
Drugs
A 12/1-4/14 FDA inspection at Sri Krishna Pharmaceuticals Unit 2 in Hyderabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 4/1 Warning Letter. Specific violations noted during the inspection included: failing to ensure that laboratory records
Drugs
FDA has posted a draft guidance on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls (CMC) Information” that provides recommendations on implementing a CMC postapproval change under a comparability protocol (CP). “Submission of a CP in an original application or prior approval supplement (PAS) allows the agency
Drugs
Allergan says that a revised FDA draft guidance on cyclosporine has improved, in certain important aspects, the scientific rigor of analyses suggested in the earlier version, but still leaves open some “fundamental gaps that prevent the 2016 draft guidance from describing in vitro analyses that could be adequate on their
Devices
FDA has classified as Class 1 a Boston Scientific recall of all models of its thrombectomy Fetch 2 Aspiration Catheter, used during procedures to remove small blood clots from coronary arteries. The recall is based on complaints about shaft breakage during the procedure, and the broken section was either removed
Drugs
FDA has approved an Avedro NDA for its Photrexa Viscous, Photrexa and the KXL System for corneal collagen cross-linking for treating progressive keratoconus. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking. Keratoconus is a progressive thinning and distortion of
FDA Policy/General
FDA commissioner Robert Califf says he is not looking to micro-manage the agency, and he believes that 95% of what FDA does operationally he should keep a distance. “The Centers are there for a reason and they have really competent experts and they make good decisions,” he said during