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Category: RLD

FDA updates list of inquiries from prospective generic drug applicants about RLD access

September 19, 2019 Blogger Leave a comment

FDA updates list of inquiries from prospective generic drug applicants about RLD access — Read on s2027422842.t.en25.com/e/es

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Posted in: RLD Filed under: gdufa, RLD

FDA OKs First Treatment for Interstitial Lung Disease Associated with Systemic Sclerosis

September 6, 2019 Blogger Leave a comment

Nintedanib (Ofev, Boehringer Ingelheim) is now the first therapy approved for patients with interstitial lung disease associated with systemic sclerosis.…

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Posted in: RLD Filed under: approvals, pdufa, RLD

Reference Listed Drug (RLD) Access Inquiries | FDA

August 20, 2019 Blogger Leave a comment

A list of all drug products about which FDA has received inquiries related to RLD access, along with details including…

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Posted in: RLD Filed under: RLD

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