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Federal efforts to protect the drug supply chain continue to bear fruit, with the FDA’s Office of Criminal Investigations announcing criminal charges for another counterfeit operation. Read More
The White House announced Monday that it plans to ask Congress for $1.8 billion in emergency funding to combat Zika, including $200 million to develop and commercialize vaccines and diagnostic tests. Read More
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Read More
The UK’s National Institute for Health and Care Excellence has given a thumbs-down to the cholesterol drug Praluent, but a tentative nod to competitor Repatha. Read More
An update from Pfizer and Allergan on their proposed megamerger provides more insight into how Allergan product lines will be worked into Pfizer’s operating structure and various executive assignments. Read More
According to the letter, Monmouth’s IRB did not provide sufficient scrutiny to pediatric research, and conducted business without a quorum of members. Read More