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The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated. Read More
Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More
Novo Nordisk will pay more than $58 million for failing to comply with FDA regulations on risk disclosures for its diabetes medication Victoza. Read More
The FDA finalized its 2015 guidance on reporting deviations for human cells, tissues and cellular and tissue-based products, also known as HCT/Ps, offering recommendations for complying with federal reporting requirements and listing the most frequent reports received by CBER. Read More
BIO and PhRMA filed a lawsuit challenging Nevada’s new price transparency law for diabetes drugs, arguing it oversteps the state’s authority. Read More
Carlton’s Dunwoody Pharmacy failed to establish a testing program, failed to prepare production records, used inadequate instruments, and violated labeling rules. Read More