FDA Inspection Authority – Know The Law
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 ...
Department of Justice Limits Use of Guidance Documents In ACE Cases
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, ...
FDA Guidance On Compounded Drugs That Are Essentially Copies Of Commercially Available Drugs
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 ...
Attorney General Ends Agency Rulemaking Through Guidance Documents
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 ...