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The Draft Guidance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International Conference on Harmonisation; Draft Guidance on ICH Q1D Bracketing and Matrixing Designs for Stability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The Draft Guidance |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 |
