Draft guidance sums up agency’s policies for determining exclusivity, clarifies when the clock starts for failure to market.
For more than a decade, ANDA sponsors have struggled with FDA over the complex rules for obtaining 180-day marketing exclusivity. The agency recently issued a guidance that answers 45 of the most commonly asked questions about the policy, which may help firms get through the labyrinth.
The draft guidance, 180-Day Exclusivity: Questions and Answers, sums up the positions FDA has taken in litigation, responses...
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Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
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.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
