The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The full Senate is scheduled to decide on Feb. 22 whether Robert Califf should be the next FDA commissioner, after Majority Leader Sen. Mitch McConnell (R-Ky.) scheduled a cloture vote late Thursday. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
The UK’s Department of Health and NHS England have failed to manage the Cancer Drugs Fund effectively by not carrying out its intended purpose and significantly outspending its budget, according to a report released by the UK Parliament’s House of Commons. Read More
New Zealand signing off on the Trans-Pacific Partnership on Feb. 3 should start the clock ticking for ratification of the treaty, which provides up to eight years of exclusivity for biologics. Read More
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More
The UK’s National Institute for Health and Care Excellence has issued recommendations for NHS to reimburse the use of seven biologicals in treating severe rheumatoid arthritis, along with four new cancer treatments and a lung disease therapy. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding compliance orders and not living up to their own promises to carry out proper cGMP practices for active pharmaceutical ingredients. Read More