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The lure of authorized generics (AGs) has caused some generics makers to jump ship and forge partnerships with brand firms, but regardless of generic drugmaker support, AG deals may start to face more FTC scrutiny over their long-term anti-competitive effects, industry experts said at the recent Institute for International Research’s annual Generic Drugs Summit.
The FDA has issued a proposed rule that would streamline cGMPs for the manufacture of positron emission tomography (PET) drugs, making it easier for drug producers to comply with federal quality requirements.
Ferreting out off-label drug fraud remains a top priority at the Department of Justice (DOJ), especially in light of the government’s aim to cut $10 billion from Medicaid and the new competitive pressures expected with next year’s Medicare prescription drug benefit, says a top DOJ official.
The FDA's final rule defining the primary mode of action (PMOA) of combination products will give firms a better understanding of how the agency determines which FDA office takes regulatory oversight of their products, says an FDA official.
Drug manufacturers that implement effective quality risk management systems could see fewer government regulators peering over their shoulders, suggests a new guidance on risk management released by the FDA.
While the FDA has agreed that some bloodsucking and flesh-eating animals should be considered medical devices, it has not yet quite figured out just how to regulate them — despite several thousand years’ worth of experience in their application by clinical practitioners and others.
The saga of troubled generic drugmaker Able Laboratories took yet another turn this month when the company said it intends to sell its assets — a move sparked by the FDA’s rejection of a consent
decree proposal that would have allowed the firm to relaunch its withdrawn drug products without having to resubmit abbreviated new drug applications (ANDAs).
Health Canada issued an advisory this week to alert patients that three erectile dysfunction (ED) drugs have been linked to reports of sudden vision loss. The action comes just two weeks after a similar warning was issued by the FDA.
Only a “very small number” of adverse events have been reported by patients using Mylan’s fentanyl pain patch — the generic version of Johnson & Johnson’s (J&J) Duragesic, for which the FDA recently issued a public health advisory — according to Mylan’s chief executive.