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FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection fo...[ Price : $8.95]
AdvaMed says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices...[ Price : $8.95]
FDA requests comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute...[ Price : $8.95]
Medtronic recalls (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations.[ Price : $8.95]
An Elucid 510(k) gains clearance for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease.[ Price : $8.95]
A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug...[ Price : $8.95]
FDA updates CDRHs Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination...[ Price : $8.95]
FDA says that 22% of new molecular entities required postmarketing requirements or postmarketing commitments to address knowledge ...