FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers about the FDA's new national priority voucher program, experts told MedPage ...
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: ...
In combination with glucocorticoids, the induction dosage of the biosimilar rituximab-aarx for patients with active ...
WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...
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