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Genentech, Inc.

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Latest From Genentech, Inc.

Quality Officers Call For New Approaches To Reduce Global Manufacturing Change Complexity

Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.

Manufacturing Quality

UTC’s Suit Against US FDA To Block Application For Tyvaso Rival Invokes Arcane ‘Bundling Rule’

United Therapeutics Corp. claims the agency wrongly allowed Liquidia to submit an amendment to add a new indication to its tentatively approved NDA for a rival version of its pulmonary arterial hypertension blockbuster treprostinil.

Litigation Intellectual Property

New Accelerated Approval Withdrawal Process More Streamlined, Marks Says

OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

Review Pathway Post Market Regulation & Studies

Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

Post Market Regulation & Studies Review Pathway
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Tanox
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