Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Changes to an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). (29DEC99)
Click here for txt or pdf                                                                            Prepublication document
Supporting Statement

Agency Information Activities; Submission for OMB Review; Comment Request; Advisory Opinion. (29DEC99)
Click here for txt or pdf                                                                                  Prepublication document

Guidance for Industry on Changes to an Approved NDA or ANDA; Availability. (23NOV99)
Click here for txt or pdf                                                                                Prepublication document                                                                                        The Guidance

Guidance for Industry: Chemistry, Manufacturing
and Control Changes to an Approved NADA or ANADA; Availability.  (01OCT99)
Click here for txt or pdf
Prepublication document
The Guidance

Wallace Laboratories et al.; Withdrawal of Approval of 18 New Drug Applications and 44 Abbreviated New Drug Applications. (23SEP99)
Click here for txt or pdf
Prepublication document

Draft Guidance for Industry on Average, Population, and Individual Approaches to Establishing Bioequivalence; Availability. (08SEP99)
Click here for txt or pdf
Prepublication document
The Draft Guidance

180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications. (06AUG99)
Click here for txt or pdf
Prepublication document

Changes to an Approved NDA or ANDA; Proposed Rule and Draft Companion Guidance (05AUG99)
Click here for txt or pdf
Prepublication document

Review of Guidances for Industry on the Development of Generic Drug Products; Development and Use of FDA Guidance Documents; Request for Comments.  (08JUL99)
Click here for txt or pdf
Prepublication document

Draft Guidance for Industry on Changes to an Approved NDA or ANADA; Availability. (28JUN99)
Click here for txt or pdf
Prepublication document

The Draft Guidance

Draft Guidance for Industry on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability  (24JUN99)
Click here for txt or pdf
Prepublication document

The Guidance

SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug Application and 38 Abbreviated New Drug Applications (21JUN99)
Click here for txt or pdf
Prepublication document

Steris Laboratories, Inc.; Withdrawal of Approval of 55 Abbreviated New Drug Applications (21JUN99)
Click here for txt or pdf
Prepublication document

"Merck & Co., Inc., et al.; Withdrawal of Approval of 32 New Drug Applications and 48 Abbreviated New Drug Applications"(10JUN99)
Click here for txt or pdf
Prepublication document

Revocation of Office of Generic Drug's Interim Policy Statement on Inactive Ingredients. [TXT]  [PDF] (30 APR99)
 Click here for txt or pdf

Draft Guidance for Industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System; Availability. (17FEB99)
Click here for txt or pdf
The Guidance .Click here for pdf

Guidance for Industry on Variations in Drug Products That May Be Included in a Single Abbreviated New Drug Application; Availability. (27JAN99)
Click here for txt or pdf
Draft Guidance .Click here for pdf

Draft Guidance for Industry on Content and Format for Geriatric Labeling; Availability. (21JAN99)
Click here for txt or pdf
Draft Guidance . Click here for pdf

Dipyridamole; Drugs for Human Use; Drug Efficacy Study Implementation; Withdrawal of Approval of Abbreviated New Drug Applications. (06JAN99)
Click here for txt or pdf

Draft Guidance for Industry on ANDA's: Impurities in Drug Products; Availability. (05JAN99
Click here for txt or pdf
The draft guidance . Click here for pdf