Industry and advocates will have to take up fight for more CDER funding after Obama depends entirely on fees for human drugs program budget increase.
The Obama administration indicated that an FDA budget increase in fiscal year 2017 is not among its priorities, placing all the pressure on agency stakeholders to fight for a funding boost outside of fee revenue.
The president requested a $358.3m increase for the agency for the next fiscal year, according to FDA's congressional...
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HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
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.
