Gilead 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…
FDA 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…
Foreign 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…
FDA 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
FDA 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…
Taiwan 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…
483 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
Proposed 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
MedTech 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…
FDA Warns Massachusetts Firm Over Uncleared Device Modifications
The FDA hit Draeger Medical Systems with a warning letter for failing to submit a new 510(k) premarket notification for “significant changes” it made to its patient monitoring device. Source:…
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