2001

International Conference on Harmonisation; Guidance on Q1A Stability Testing of New Drug Substances and Products; Availability.    (07NOV01)
Click here for
txt or pdf
Prepublication display
The Guidance

OC 2001253.  Request for Participants at the Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science.    (25OCT01)
Click here for
txt or pdf
Prepublication display

International Conference on Harmonisation; Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients; Availability.    (25SEP01)
Click here for
txt or pdf
Prepublication display
The Draft Guidance

International Conference on Harmonisation; Draft Guidance on ICH Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products; Availability.    (25SEP01)
Click here for
txt or pdf
Prepublication display
The Draft Guidance

Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements.    (25SEP01)
Click here for
txt or pdf
Prepublication display

Current Good Manufacturing Practice for Active Pharmaceutical Ingredients; Public Workshops Beginning October 22, 2001 through April 10, 2002.    (24SEP01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Current Good Manufacturing Practice (CGMP), Quality System (QS) Regulation.    (20JUL01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles.    (15JUN01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds.   (15JUN01)
Click here for
txt or pdf
Prepublication display

Advisory committee for Pharmaceutical Science; Notice of Meeting.   (14JUN01)
Click here for
txt or pdf
Prepublication display

Orally Inhaled and Nasal Drug Products Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of Meeting.    (14JUN01)
Click here for
txt or pdf
Prepublication display

General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification.    (11JUN01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation. (31MAY01)
Click here for
txt or pdf
Prepublication display

Guidance for Industry on Ind Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability.    (25MAY01)
Click here for
txt or pdf
Prepublication display
The Guidance

Guidance for Industry on Bioanalytical Method Validation; Availability.    (23MAY01)
Click here for
txt or pdf
Prepublication display
The Guidance

OC 200184.  Agency Information Collection Activities; Announcement of OMB Approval; Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation.  (01MAY01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Agency Information Collection Activities; Announcement of OMB Approval; Biological Products: Reporting of Biological Product Deviations in Manufacturing  (01MAR01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation  (28FEB01)
Click here for
txt or pdf
Prepublication display

Guidance for Industry on BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation; Availability.  (16FEB01)
Click here for
txt or pdf
Prepublication display
The Guidance

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles.  (09FEB01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds.  (09FEB01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation (Formerly Known and Approved Under Sterility Requirements for Inhalation Solution Products)  (03JAN01)
Click here for
txt or pdf
Prepublication display