India May Impose Price Controls on More Medical Devices June 29, 2017 The NPPA has called for a stakeholder consultation. Read More
FDA Taking Comments on BsUFA II Review Assessment Project June 29, 2017 To accommodate the increased interaction, the FDA said its review clock will begin after a 60-day administrative filing review period. Read More
FDA Hits Oakworks Over Unreported Changes, Record-Keeping, Complaints June 28, 2017 The firm made alterations to devices without reporting the changes in writing to the FDA. Read More
Nonprofit Sues Celgene for Blocking Generic Competition June 28, 2017 Celgene blocked development of generics for the two medicines, the suit claimed. Read More
FDA Hits Kronner Over Complaints, Reporting Procedures June 27, 2017 The company failed to document verification or validation of corrective actions taken in response to two complaints. Read More
Jury Awards GSK $235 Million After Teva Added Heart Failure Indication to Generic Coreg June 27, 2017 The jury rejected Teva’s claim that the patent cited was invalid and awarded GSK $234.1 million in lost profits. Read More
FDA’s Generic Drugs Office Passes Last Year’s Record for ANDAs Received June 26, 2017 The upward trend seems to be slowing, however, as the end of the fiscal year approaches. Read More
Senate Healthcare Bill Would Repeal Medical Device Excise Tax June 26, 2017 The House bill included the same provision. Read More
Brazil’s ANVISA Now Accepts Both Electronic and Paper Submissions June 23, 2017 Medical device registration submissions can now be submitted in multiple formats. Read More
FDA Draft Guidance Calls for Early Correspondence to Speed ANDA Review June 23, 2017 FDA’s new guidance will shorten review timeline. Read More
Zimmer Biomet Cleaned House After FDA Inspection at Warsaw Plant June 22, 2017 Zimmer replaced five operations and quality executives after FDA inspection. Read More
Manufacturers Receive FDA Warnings on Steroids Masquerading as Supplements June 22, 2017 Drugs masquerading as designer steroids are linked to health risks. Read More