Drugs
Nicox SA has submitted through its American subsidiary Nicox Ophthalmics, Inc., an NDA to FDA seeking approval of AC-170, its cetirizine eye drop formulation, for treating ocular itching associated with allergic conjunctivitis. The company says it is also seeking priority review based on clinical pediatric data generated with AC-
Drugs
A just-released FDA-483 issued following a 3/14-3/25 inspection at Catalent Pharma Solutions, St. Petersburg, FL, lists 14 violations, including: failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or
Drugs
An analysis in the Journal of the American Medical Association says that FDA’s Sentinel Initiative has moved from a pilot program to being operational, but still has not reached its full potential. While some observers have heralded developments so far as major achievements, the report notes, only a handful
Devices
FDA says its adverse event data through 12/31/15 show 294 reports of pregnancy loss in patients reporting use of Bayer’s Essure sterilization device. The FDA statement is included in the agency’s response to Rep. Michael Fitzpatrick (R-PA), who has called for the device to be
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