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FDA introduces patent submission date updates to the Orange Book
The U.S. Food and Drug Administration (FDA) today introduced an important data update to Approved Drug Products with Therapeutic Equivalence...
IPEC rolls out guide to reflect changing pharma excipient landscape
The International Pharmaceutical Excipient Council (IPEC) has updated its Quality Agreement guidelines to reflect changing regulatory expectations...
FDA to Revise 20-Year-Old ICH Reproductive Risks Guideline
The FDA published an ICH-developed revision to its industry guideline on the detection of reproductive risks in new drugs.
The draft guideline...
FDA Expands ANDA Prioritization Policy
Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly...