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The FDA has selected 13 drugmakers to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More
Troubled drug compounder and repackager Medisca has landed in hot water with the FDA again after the agency found a different type of drug in recalled lots of L-citrulline. Read More
The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients. Read More
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More
The FDA is expanding the types of documents that drugmakers can distribute to physicians that discuss off-label drug uses, loosening its limits on clinical practice guidelines (CPGs) and medical textbooks. Read More
Drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More