March 28, 2018: Kristin Pierson and Paige McKinney file amicus curiae brief in the Georgia Court of Appeals on behalf of the Georgia Defense Lawyers Association addressing the admissibility of ...
In light of the memos released by Attorney General Jeff Sessions and Associate Attorney General Rachel Brand in recent months indicating that FDA guidance documents are non-binding and that noncompliance ...
On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum to all United States Attorneys and the Heads of the Department of Justice’s Litigating Components instructing them that, ...
To qualify for the exemptions from certain requirements of the Food, Drug and Cosmetics Act (“FDCA”), compounded drugs may not be “essentially copies of commercially available drug products.” On January ...
On November 16, 2017, Attorney General Jeff Sessions issued a memorandum which calls for an end to government agencies regulating through guidance documents, as if guidance documents were equivalent to ...
