The Effect of the DOJ Memo, "Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases," On FDA Inspections of Compounding Pharmacies and Outsourcing Facilities

The Effect of the DOJ Memo, "Limiting Use of Agency Guidance ...

JD Supra (press release)-5 hours ago

For years, the Food and Drug Administration (FDA) has relied upon draft and final guidance policies as the basis of Form 483 inspectional observations. A recent memorandum issued on January 25, 2018 by the Attorney General clearly prohibits the use of guidance documents in civil enforcement cases to effectively bind ...