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In comments on the FDA’s draft guidance on the Usage and Indication sections of drug labeling, Novartis and Pfizer asked the agency to clarify its thinking on limitations of use. Read More
In the latest salvo in the federal crackdown on fraud among Florida compounders, a federal jury convicted pharmacist Stephen Chalker of participating in a $5 million scheme to defraud Medicare, Medicaid and TRICARE. Read More
A California federal judge dismissed a shareholder suit against Impax Laboratories alleging price-fixing but left the door open for an amended complaint. Read More
The FDA issued guidance Monday on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More
FDA Commissioner Scott Gottlieb announced a revised agreement Friday between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Read More