viernes, 20 de octubre de 2017

FDA seeks input on product-specific guidances to facilitate generic drug development (corrected)

https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery&elqTrackId=bea3ce5d4d684079919a2e5b16581a52&elq=1e6b4fc768e84629a6537d29f5bc1447&elqaid=954&elqat=1&elqCampaignId=503
U.S. Food and Drug Administration Header
FDA seeks input on product-specific guidances to facilitate generic drug development (corrected)

FDA has published 51 product-specific guidances (32 new and 19 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.

FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances.

For more information and to view the guidances, visit:

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