FDA Grants Clearance to Roche’s Anti-Mullerian Hormone Test Elecsys January 6, 2017 The assay relies on blood samples to assess the ovary’s capacity to provide egg cells. Read More
Spanish Regulator Suspends Manufacturing Authorization of Drugmaker for GMP Lapses January 6, 2017 Angulema failed to implement an effective pharmaceutical quality system to ensure vaccines met production standards. Read More
FDA Clears Flashback Technologies’ Compulsory Reserve Index Application January 5, 2017 The compulsory reserve index is an adjunctive cardiovascular indicator of changes in blood volume. Read More
Draft Guidance Will Streamline Submissions of Manufacturing Establishment Information January 5, 2017 The guidance allows drugmakers to streamline required information on the manufacturing establishments. Read More
Luminex Receives Clearance for its ARIES Streptococcus Assay for Pregnant Women January 4, 2017 FDA clears automated streptococcus assay for CDC-recommended screening of pregnant women. Read More
Japan Looks to Cut Drug Prices, with Annual Reviews January 4, 2017 Japan plans to cut the price of Bristol-Myers Squibb’s cancer drug Opdivo by 50 percent. Read More
Hong Kong Issues Warnings for Pacing Leads, Stents, Ventilators January 3, 2017 The warnings prompted a voluntary recall and medical device safety alerts. Read More
FDA 483 Finds Deficiencies at Baxter Healthcare Facility in Puerto Rico January 3, 2017 The FDA investigators listed 10 deficiencies at the Baxter facility. Read More
Aesculap Gets Form 483 for Untimely Reports December 30, 2016 Inspectors uncovered that the manufacturer had not filed about 25 medical device reportable events. Read More
Teva to Settle DOJ, SEC Foreign Bribery Charges for $519 Million December 30, 2016 The settlement includes a guilty plea from the company’s subsidiary in Russia. Read More
Sight Sciences Gains Health Canada Approval for the TRAB 360 Trabeculotomy System December 29, 2016 The device is inserted via a single, sub-2mm, clear corneal incision. Read More
FDA Requests Analyses, Inspection Fixes in CRL to Advanced Accelerator Applications for Tumor Therapy December 29, 2016 The company must also resolve observations from FDA inspections of the manufacturing facilities. Read More