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Julia Post
Julia F. Post
Associate
Washington +1 202 662 5249 jpost@cov.com Download V-card

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Ms. Post has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Ms. Post was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

  • Represent biotechnology innovators regarding the BPCIA and FDA implementation of the biosimilars pathway, including preparation of comments on FDA draft guidance and citizen petitions.
  • Develop citizen petitions for innovative companies regarding bioequivalence and other testing standards for generic drugs and related labeling requirements.
  • Advise biotechnology clients on approval pathways and regulatory considerations for innovative HCT/Ps.
  • Advise clients regarding regulatory and legislative developments for biologics and drugs.
  • Advise pharmaceutical and biotechnology companies regarding state laws and regulations governing generic drug and biosimilar substitution.
  • Represented a major pharmaceutical company in Hatch-Waxman litigation against generic drug manufacturers concerning oral formulations used to treat ulcerative colitis.
  • Represented a pharmaceutical company in an ANDA case concerning a topical formulation used to treat actinic keratosis.

Pro Bono

  • Serving as guardian ad litem in a child custody dispute in D.C. Superior Court.

Previous Experience

  • Booz Allen Hamilton, Consultant (2006-2007)
  • The Johns Hopkins Berman Institute of Bioethics, Research Assistant (2005-2006)