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The FDA is still not convinced that Sprout Pharmaceutical’s libido-enhancing drug for women is safe, particularly when mixed with alcohol, and has asked two of its advisory committees to consider whether alcohol should be contraindicated in the product’s labeling. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said Monday, adding that the current system of different expectations is not sustainable. Read More
A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for drugmakers to sue for patent infringement, a patent law attorney said. Read More
Drugmakers seeking marketing authorization in the EU may request a meeting with the European Medicines Agency to discuss questions posed by the agency’s advisory committees, updated guidance says.
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