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The European Medicines Agency is pairing up with various governments’ policy review boards to streamline consultations with drug companies following a successful test run of the effort. Read More
The FDA has approved a supplemental application for abortion drug Mifeprex, updating the label to lower the dosage and extend the usage period to 70 days gestation from 49. Read More
Pricing transparency is a key ingredient in bringing down prescription drug costs, according to a policy paper from the American College of Physicians. Read More
The FTC is suing Endo Pharmaceuticals and several other drugmakers over what it calls the illegal use of pay-for-delay settlements to block the market entry of generic forms of Opana ER and Lidoderm. Read More
Following months of pressure from industry, the FDA has released draft guidance on biosimilars labeling, recommending that sponsors of biosimilars incorporate into product labeling information from the reference product labeling. Read More