Archive for February 2020
Indian Drugmaker Cited in EU for Serious GMP Violations
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection. Source: Drug Industry Daily
Read MoreGilead Loses PTAB Patent Challenges
In a further blow to Gilead, the U.S. Patent Trial and Appeal Board (PTAB) denied the company’s request to review two HHS patents for the use of Truvada (emtricitabine/tenofovir) for prevention of HIV infection. Source: Drug Industry Daily
Read MoreFDA Revises Guidance on Electronic Drug Submissions
The FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver. Source: Drug Industry Daily
Read MoreForeign Governments ‘Free-Riding’ on U.S. Drug Research, White House Says
The U.S. is bearing the brunt of pharmaceutical research costs because of “free-riding” by foreign countries in the past 15 years, the White House Council of Economic Advisers (CEA) claimed in a new report released yesterday. Source: Drug Industry Daily
Read MoreFDA Publishes Details on Gene-Drug Interactions
The FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling. Source: Drug Industry Daily
Read MoreFDA Schedules Workshop on Virtual And Augmented Reality in Medicine
The FDA will hold a March 5 workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland. Source: The GMP Letter
Read MoreTaiwan Includes Quality Requirements in New Medical Device Law
Taiwan’s legislature passed the Medical Device Management Law, separating the country’s regulation of medical devices from pharmaceutical products for the first time — and introducing new requirements for quality management systems. Source: The GMP Letter
Read More483 Roundup: Six Facilities Cited for Quality Lapses
The FDA rapped six U.S. devicemakers for numerous GMP and quality deficiencies found during inspections of their facilities. Source: The GMP Letter
Read MoreProposed Bill Would Allow FDA to Destroy Counterfeit Products
U.S. lawmakers are considering a bipartisan bill that would give the FDA authority to destroy counterfeit medical devices. Source: The GMP Letter
Read MoreMedTech Europe Renews Alarm Over MDR Transition
Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in a new status report. Source: The GMP Letter
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