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The Pennsylvania Supreme Court has affirmed that drugmakers can be held liable for negligent drug design, opening up a new avenue for patients seeking financial relief for injury claims in the state. Read More
The Supreme Court on Wednesday, in a closely-watched case, issued a unanimous 9-0 ruling stating that regardless of whether a patent holder is the plaintiff or defendant in a patent infringement case, the burden-of-proof for infringement remains with the patent holder. Read More
Ranbaxy’s regulatory woes deepened Thursday as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
A key panel of the European Parliament on Wednesday advanced draft legislation revising EU clinical trial regulations, setting up a final vote for replacing the current trial directive in April. Read More
A new Tufts University report praises the FDA’s breakthrough therapy program for its potential to advance new drugs and biologics targeting unmet needs. Read More
A group of 28 Republican lawmakers is adding to the avalanche of opposition to the FDA’s proposed generic drug safety labeling rule, saying it will sow confusion and increase drug costs. Read More
If an EU nation finds a safety issue with a drug and flags it for review, that decision will start a 60-day clock during which a drugmaker will have the opportunity to resolve all concerns about the product or face revocation or modifications to its market authorization. Read More
Drugmakers should routinely assess the effectiveness of “dear healthcare provider” letters that provide updated safety or usage information about a drug and make improvements where needed, the FDA said Wednesday. Read More
FDA reviewers have unveiled the top five reasons for drug approval delays and denials over a twelve-year period, noting that many could be avoided if drugmakers submitted more accurate and useful information. Read More