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The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Jan. 14, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. 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
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
The FDA is continuing its efforts to improve the ANDA approval process, this time asking generics makers to provide comments on what elements of the process are creating stumbling blocks and how the agency can help clear them away. Read More