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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regarding the BPCIA and FDA implementation of the biosimilars pathway, including preparation of comments on FDA draft guidance and citizen petitions.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)
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
July 23, 2020, Covington Alert
FDA announced this week that it intends to extend its enforcement discretion policy regarding investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products through May 2021. In light of the COVID-19 emergency, manufacturers will have six additional months after the initial November 2020 deadline to prepare and ...
July 14, 2020, Covington Alert
On July 3, 2020, the Standing Committee of the National People’s Congress (“NPC”) of China published a second draft amendment (the “Draft”) on the Patent Law of the People’s Republic of China (“Patent Law”). Most notably among the Draft’s proposed 29 revisions to the Patent Law, the Draft includes high-level provisions that would establish a framework for early ...
April 29, 2020, Covington Alert
On March 30, 2020, the State Administration of Market Regulation of China, the parent agency of the National Medical Products Administration (NMPA), released a revised Drug Registration Regulation (Revised DRR).
April 6, 2020, Covington Alert
This alert provides an update on the regulatory measures regarding medical-use and industrial-use personal protective equipment (PPE) from China to combat COVID-19, including a brief summary of measures the U.S. Food and Drug Administration (U.S. FDA) is taking to facilitate import of PPE from China into the United States. The regulatory guidance from both ...
April 2, 2020, Covington Alert
On March 27, the U.S. Food and Drug Administration (FDA) updated its guidance entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Updated Guidance).
March 22, 2020, Covington Alert
The U.S. Food and Drug Administration (FDA) released guidance on March 19, 2020 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” (Guidance). The Guidance revises FDA’s February 2012 final guidance for industry on adverse event reporting during an influenza pandemic to clarify that the guidance ...
March 19, 2020, Covington Alert
The U.S. Food and Drug Administration (FDA) released guidance on March 18, 2020 entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Guidance).1 The Guidance comes at a critical time, as clinical trial sponsors, investigators, and Institutional Review Boards (IRBs) grapple with the measures needed to ensure the ...
October 8, 2019
WASHINGTON—A federal jury in the U.S. District Court for the District of Kansas today ruled in favor of Covington client Julie Burkhart, founder and CEO of pro-choice and reproductive justice organization Trust Women in Wichita, following a case brought against Ms. Burkhart by a prominent anti-abortion activist. The case involved two incidents in November 2012 ...
September 9, 2019, Covington Alert
On August 26, 2019, China’s Standing Committee of National People's Congress (“NPC) adopted a significant revision of the Drug Administration Law (“DAL”). The newly adopted DAL (“Revised DAL”) will go into effect on December 1, 2019. The Revised DAL is the first overhaul of the DAL since 2001.
July 27, 2018, Covington Alert
On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.
March 15, 2018, Covington Alert
On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs.
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...
June 29, 2017, The American Journal of Bioethics, 17:7, 51-53
March 28, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
February 27, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
December 28, 2012, Covington E-Alert
December 3, 2012, Covington E-Alert
October 31, 2012, Covington E-Alert
September 28, 2012, Covington E-Alert
August 31, 2012, Covington E-Alert
July 26, 2012, Covington E-Alert
June 11, 2012, Covington E-Alert
May 29, 2012, Covington E-Alert
April 30, 2012, Covington E-Alert
March 22, 2012, Covington E-Alert
February 29, 2012, Covington E-Alert
Education
University of Michigan Law School, J.D., 2010
- cum laude
- University of Michigan Journal of Law Reform, Managing Notes Editor
Johns Hopkins University, B.A., 2005
- with honors