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	Regulatory Inprocess Changes Process Validation and Out of Specification Findings
	Patent Term Extension Sample Format For Submission
	GMP Regulations 21 GFR Parts 210 and 211
	Human Drug GMP Notes  June 2000, March 2000, Sept 2000
	Policies and Procedures Submission of Electronic Case Reports
	International Agreement Documents (available from the FDA Office of Regulatory Affairs) Belarus: MOU with Belarus regarding information exchange for drugs and biologics. (Mar 27/96) Canada: Agreement of cooperation with Canada on exchange of drug plant inspection information (Oct 1/73) (Bilateral Agreement) MOU on Good Laboratory Practices (May 10/79) Drug GMP Information Exchange Good Laboratory Practices Germany: MOU on Good Laboratory Practices (Dec 23/88) Italy: MOU on Good Laboratory Practices (Dec 19/88) Japan: Note Verbale with Japan on Good Laboratory Practices (Apr 15/83) Russia: MOU with Russia on drugs and biological products (Feb 2/97) United Kingdom: Medical Device Inspection Canada and Mexico: Memorandum of Cooperation with Canada and Mexico on cooperation in the scientific and regulatory fields (Oct 30/95) Submission of Electronic Case Reports Information Exchange FDA International Contacts: Office of International Programs
	Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements; Proposed Rule Thursday February 6, 1997 -- Part IV Department of Health and Human Services Food and Drug Administration