FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. China Resources Zizhu Pharmaceutical Co., Ltd. Beijing, China (4/24): FDA inspected the firm and cited significant GMP deviations associated with its active pharmaceutical ingredients manufacturing. For example, the
Drugs
An 11/28-12/1/16 FDA inspection at Qinhuangdao Zizhu Pharmaceutical Co., Beijing, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) according to a just-released 4/24 Warning Letter. Specific deviations included: * failing to prevent unauthorized access or changes to data,
Drugs
A 4/18-6/28/16 FDA inspection at Sewaren Innovative Pharmaceutical Packaging, Avenel, NJ, found that the firm failed to meet conditions required for exemption from some drug compounding regulations. A 5/22 Warning Letter from the agency’s New Jersey District Office says the investigator found that the
Drugs
FDA has issued a draft guidance with questions and answers providing guidance to sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic records and electronic signatures in clinical investigations of medical products. The document clarifies, updates, and expands upon recommendations in a 2003
Devices
FDA has just released Zimmer Biomet’s detailed 12/21/16 response to observations in an FDA-483 issued 11/22/16 following an inspection at the company’s Warsaw North Campus in Warsaw, Indiana. “We recognize and take seriously the significance of the observations in the FDA-483, are
Devices
FDA has cleared Hologic’s Aptima herpes simplex virus (HSV) 1 and 2 molecular assay that operates on its Panther system. The company says the assay can be used to qualitatively detect and differentiate between HSV 1 and HSV 2. Specimens collected in a broad range of transport media, including
Drugs
FDA commissioner Scott Gottlieb has pledged to revamp the new drug development process for targeted drugs. Testifying before a Senate Appropriations subcommittee hearing 6/20, Gottlieb acknowledged that the “most tangible way we are going to reduce healthcare costs is by finding better treatments for a lot of costly diseases.
Devices
FDA has cleared a ConforMIS 510(k) for the iTotal Hip replacement system. The device features the company’s proprietary iFit technology, which is similar to that used to design, manufacture and deliver customized knee implants, according to the company. “The system utilizes ConforMIS’s patient-specific technology, single-use
Devices
FDA has cleared a Medicrea Group 510(k) for UNiD HUB, a data-driven digital portal for the company’s Adaptive Spine Intelligence. The device is designed to “support the surgeon workflow, identify tendencies and correlations and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions
Drugs
Seattle Genetics says it is discontinuing its Phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia patients due to a higher rate of deaths seen in those on the therapy. The company made its decision after consulting with its independent data monitoring committee
Drugs
FDA has issued a draft guidance on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions. During user fee negotiations, the agency and industry agreed to pre-submission facility correspondence (PFC) to help obtain a shorter GDUFA goal date for priority ANDAs, their amendments, and prior approval supplements. The document
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Pharmacogenomic Data Submissions; OMB Control Number 0910–0557.” The guidance provides recommendations to sponsors submitting or holding INDs, NDAs, or BLAs on what pharmacogenomic data should be submitted during the drug development
Drugs
Alvogen has recalled seven lots of clindamycin injection USP ADD-Vantage Vials due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. The drug is indicated for treating serious infections caused by susceptible bacteria. Its use should
Devices
Datascope Corp. has begun a field correction involving certain Intra-Aortic Balloon Pumps due to a potential electrical test failure code. This action also applies to any System 98 or System 98XT pump that was converted to a CS100i or CS300 pump. The company says it received a complaint that
FDA Policy/General
Federal Register notice: FDA has proposed a new drug advertising study entitled “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The study is intended to examine how repetition and over-warning apply to risk presentations in direct-to-consumer print advertising. The research aims
FDA Policy/General
Federal Register notice. FDA is seeking comments on an information collection extension for requirements for accepting “Electronic Records; Electronic Signatures — 21 CFR Part 11; OMB Control Number 0910–0303.” To view the notice, click here.
FDA Policy/General
Federal Register notice. FDA is seeking comments on an information collection extension for “Common European Medicines Agency (EMA)/FDA Application Form for Orphan Drug Medicinal Product Designation (Form FDA 3671).” To view the notice, click here.
FDA Policy/General
FDA Seeks Nominations for Radiation Standards Panel Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. 06/16/2017 FDA Seeks Consumer Reps for Advisory Panels Federal Register notice: FDA requests nominations for voting and nonvoting consumer representatives to
Drugs
FDA is alerting healthcare professionals about an ongoing shortage affecting several injectable drugs made by Pfizer’s Hospira unit, including sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), and emergency syringes of other drugs, including epinephrine, calcium chloride and atropine sulfate. Pfizer says the shortage is
Drugs
Advanced Pharma (also known as Avella of Houston) has recalled all unexpired lots of nitroglycerin products that were produced at its Houston location between 3/3 and 5/31. The recall is based on laboratory test results indicating a lower than expected potency on certain compounded lots of nitroglycerin injection,
FDA Policy/General
FDA’S Center for Veterinary Medicine (CVM) 6/16 called for applications for grants as high as $450,000 to support the development of new animal drugs intended for minor species or minor uses in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens). The Center’s announcement listed
Devices
New research finds that 37% (33 out of 89) heater-cooler units assessed between 7/2015 and 12/2016 tested positive for Mycobacterium chimaera associated with fatal infections in open-heart surgery patients. The research was recently presented at the 44th Annual Conference of the Association for Professionals in Infection