FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.
Advocates remain worried about the potential for an overhaul of the 180-day exclusivity incentive for generic drugs now that legislative text of the US Food and Drug Administration’s proposal has surfaced.
The House and Senate versions of the bill so far do not include any adjustments, but with the Senate committee...
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A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
