A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in a lengthy warning letter from the agency detailing sterility concerns. Source: Drug…
A U.S. appeals court revived a whistleblower lawsuit against Gilead Pharmaceuticals that accused the drugmaker of lying about its HIV drugs. Source: Drug Industry Daily
The FDA approved the most generic drugs during May and June that is has since it began tallying approvals, according to the agency’s latest report on the generics program —…
At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations…
Companies will need to report within 48 hours from discovery if a medical device sold in Malaysia presents a serious threat to the public health according to new requirements released…
A new study of the four biggest makers of pacemaker systems found thousands of software vulnerabilities, highlighting an industry-wide problem with software security updates. Source: The GMP Letter
Both houses of Australia’s Parliament passed a new law to amend the Therapeutic Goods Act 1989 to enable certain variations that do not impact quality, safety or efficacy to be…
The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Source: The GMP Letter
How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans? Source: The GMP Letter
As of June 1, South Africa has its first regulatory system for medical devices and in vitro diagnostics, which will include new quality management requirements. Source: The GMP Letter