Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; Availability.
(21DEC99)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data
Analysis, and Impact on Dosing and Labeling; Availability". (07DEC99)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Draft Guidance for Industry on Labeling of Over-the-Counter Human Drug Products Using a Column Format; Availability,
(01DEC99)
Click here for txt or pdf
Prepublication document
Draft Guidance |
Guidance for Industry on In Vivo Drug Metabolism/Drug Interaction Studies_Study Design, Data Analysis, and
Recommendations for Dosing and Labeling; Availability. (24NOV99)
Click here for txt or pdf
Prepublication document
The Guidance |
Progestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient. (16NOV99)
Click here for txt or pdf
Prepublication document
|
Medical Devices; Draft Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for
Medical Gloves; Availability. (16NOV99)
Click here for
txt or pdf
Prepublication document
Draft Guidance |
Physician and Patient Labeling for Progestational Drug Products; Warnings and Contraindications. (16NOV99)
Click here for txt or pdf
Prepublication document
|
Regulatory Policy on the Disposition of Publications That Constitute Labeling; Draft Revised Compliance Policy Guide (CPG
7153.13); Availability. [TXT] [PDF] (27APR99). Click here for
txt or pdf
Draft Guidance. Click here for pdf |
Draft Guidance for Industry on Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling; Availability;
Reopening of Comment Period. [TXT] [PDF] (22APR99)
Click here for txt or pdf |
Over-The-Counter Human Drugs; Labeling Requirements; Correction. [TXT] [PDF] (15APR99)
Click here for txt or pdf |
Progestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient. Click here for txt or pdf (13APR99) |
Physician Labeling and Patient Labeling for Progestational Drug Products; Warnings and Contraindications. Click here for
txt
or pdf (13APR99) |
Agency Information Collection Activities: Proposed Collection; Comment Request; Labeling Requirements for Color Additives (Other
Than Hair Dyes) and Petitions.Click here for txt or pdf (12APR99) |
Food Labeling: Declaration of Ingredients.Click here for txt or pdf (09APR99) |
Implementation of the Food and Drug Administration Modernization Act; Provisions for Use in Food Labeling of Health Claims and Nutrient
Content Claims Based on Authoritative Statements; Public Meeting; Correction. Click here for txt or pdf (02APR99) |
Agency Information Collection Activities; Announcement of OMB Approval; Food Labeling: Nutrition Labeling
of Dietary Supplements on a 'Per Day' Basis. (25MAR99)
Click here for
txt or pdf
Supporting Statement. Click here for pdf |
Over-The-Counter Human Drugs; Labeling Requirements. (17MAR99)
Click here for txt or pdf |
Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional
Labeling; Availability. (12MAR99)
Click here for txt or pdf
Guidance . Click here for
PDF |
Agency Information Collection Activities; Announcement of OMB Approval; Prescription Drug Product Labeling,
Medication Guide Requirements. (26FEB99)
Click here for txt or pdf
Supporting Statement. Click here for pdf |
Draft Guidance for Industry on Placing the Therapeutic Equivalence Code on Prescription Drug Labels and
Labeling; Availability. (28JAN99)
Click here for txt or pdf
THE GUIDANCE . Click here for pdf |
Food Labeling: Use on Dietary Supplements of Health Claims Based on Authoritative Statements. (21JAN99)
Click here for
txt or pdf |
Draft Guidance for Industry on Non-Contraceptive Estrogen Class Labeling; Availability; Reopening of
Comment Period. (08JAN99)
Click here for txt or pdf |
