MANUAL OF POLICIES AND PROCEDURES
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`MAPP 4520.]
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`Office of Training and Communications
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`Communicating Drug Approval Information
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`CONTENTS
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`PURPOSE
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`BACKGROUND
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`DEFINITIONS
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`POLICY
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`RESPONSIBILITIES & PROCEDURES
`EFFECTIVE DATE
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`PURPOSE
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`This MAPP establishes procedures for clearing drug approval information through
`Freedom of Information (FOI) staff and posting it to CDER’s Internet Web Page and
`the CDER Fax-on-Demand system. For new drug applications (NDAS), this MAPP
`addresses approval letters and approved labeling text, or final printed labeling (FPL),
`and tentative approval letters without labeling. For abbreviated new drug applications
`(ANDAS), this MAPP addresses approval and tentative approval letters only.
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`BACKGROUND
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`NDA and ANDA approval and tentative approval actions are of considerable interest
`both inside and outside the U. S. Food and Drug Administration (FDA). MedWatch,
`the FDA district offices, the trade press, competitor companies, individual practitioners,
`consumers and international FDA counterparts are among those interested in the status
`of approval actions. Therefore, when an application is approved, it is important that
`FDA make this information available as quickly as possible.
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`Originator: Director, Office of Training and Communications
`3/25/93
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`ICOS Exhibit 2007
`Mylan v. ICOS
`lI’R2017-00323
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`ICOS Exhibit 2007
`Mylan v. ICOS
`IPR2017-00323
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`MAPP 4520.1
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`DEFINITIONS
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`Applicant: The pharmaceutical firm or other party that submits a drug marketing
`application to FDA for approval.
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`Approval Letter (21 CFR 314.105): A letter from FDA to an applicant approving an
`application for marketing a drug product in the United States. Use of the term
`approval letter throughout this MAPP refers both to approval letters and tentative
`approval letters.
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`Approvals Distribution List: An internal e-mail system distribution list that identifies
`key FDA individuals who receive information about just-approved drug products.
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`Approved Labeling Text: The final approved text and graphics of the package insert
`component of labeling. This document is ordinarily a word-processing document that
`provides the applicant with the approved package insert text and graphics for use in
`final printed labeling (FPL). It does not contain hand-written notes.
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`CDER Fax-on-Demand: A computerized telecommunication system that allows users
`to request certain FDA/CDER releasable documents by phone and to receive them via
`facsimile.
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`CDER’s Web Page: An Internet web site containing CDER information that is
`accessible to the public. Only information that is disclosable to the public will be
`available on the CDER Web Page.
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`Final Printed Labeling (FPL): Denotes the approved package insert.
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`Tentative Approval Letter [21 CFR 314.105(a) and (d)]. A letter from FDA to an
`applicant stating that all scientific and procedural conditions for approval have been
`met; however, the approval has a delayed effective date usually because product
`marketing is blocked by some form of marketing exclusivity. An approval with a
`delayed effective date does not become final until FDA issues an approval letter. Use
`of the term approval letter throughout this MAPP refers both to approval letters and
`tentative approval letters.
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`Webmaster: CDER staff who manage the CDER Internet Web Page.
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`Originator: Director, Office of Training and Communications
`3/25/98
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`MAPP 4520.1
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`POLICY
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`Approval and tentative approval letters for new and generic drugs will be made
`available to all interested parties via CDER’s Web Page and the CDER Fax-on-
`Demand system within the time frames specified in this MAPP, a period not to exceed
`three working days.
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`Approved labeling text or final printed labeling for new drugs, but not for tentatively
`approved new drugs or for generic drugs, also will be made available on CDER’s Web
`Site and the CDER Fax-on-Demand system within the time frames specified in this
`MAPP, a period not to exceed three working days.
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`For original NDAS, the Office of Review Management (ORM) will include with the
`approval letter the approved labeling text if the application was approved based on
`draft labeling. Otherwise, the FPL will be included. For ANDAs, only the approval or
`tentative approval letter will be made available.
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`RESPONSIBILITIES AND PROCEDURES
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`Office of Review Management project management (PM) staff assigned to the new
`drug product:
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`Request an electronic version of the draft labeling text (preferably in Word or
`PDF format) if the applicant has not submitted an electronic version of the draft
`package insert with the application. If an applicant cannot provide the draft
`package insert in electronic format, the division will be responsible for
`producing an electronic version.
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`Until an electronic system supplies the approval or tentative approval letter’s
`date, type within the letter header information area the date the approval letter
`is signed.
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`Ensure that a copy of the approval letter and the approved labeling text is sent
`via fax to the applicant’s official regulatory contact within one business day of
`the signing of the approval letter and confirm receipt by phone. For
`applications approved with FPL, only the approval letter needs to be sent to the
`applicant.
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`4.
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`Within one business day of receipt confirmation:
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`Originator:
`3/25/98
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`Director, Office of Training and Communications
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`MAPP 4520.1
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`a. Send an e-mail to the Approvals Distribution List (APPROVALS:) that
`contains the following information:
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`NDA number
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`drug name (generic and trade name)
`applicant name
`approval or tentative approval date
`possible effective date for a tentative approval
`chemical and therapeutic classification
`indication(s)
`route of administration
`Rx or OTC
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`b. Transmit the dated approval letter and approved labeling text to the secured
`computer shared area (\\cdfda\drugapp). The preferred format for these
`documents is Word or Portable Document Format (PDF). If labeling is hard-
`copy FPL only, it should be faxed to CDER FOI at (301) 827-4576. The
`naming convention for these electronic documents is as follows:
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`The file name is the application number without the leading zero
`followed by ltr for the approval letter, lbl for the approved labeling text,
`and)2)! for the final printed labeling.
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`.doc is the extension for documents submitted in Word format and .pdf
`for PDF format. Plain text formats, such as ANSI (Windows) or ASCII
`(DOS) should have .txt as the extension. Documents may also be
`submitted in WordPerfect format using .wpd as an extension during the
`transition period to the recommend word processing package.
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`For example, application number 020701 would have two files transmitted:
`20 701 ltr. doc for an approval letter in Word format and 2070] lb].paffor the
`approved labeling text in PDF format. If the documents cannot be transferred
`in any of the above formats, a copy should be faxed to FO/I.
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`5.
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`Ensure the confidentiality and useability of the secured computer shared area
`(\\cdfda\drugapp) by promptly notifying OIT staff of personnel changes due to
`incoming or departing project managers and consumer safety officers.
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`Office of Generic Drugs project management (PM) staff assigned to the generic drug
`product:
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`Originator: Director, Office of Training and Communications
`3/25/98
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`MAPP 4520.1
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`1.
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`2.
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`letter’s
`Until an electronic system supplies the approval or tentative approval
`date, type within the header information area the date the approval letter is
`signed.
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`Ensure that a copy of the approval letter is sent via fax to the applicant’s official
`regulatory contact within one business day of the signing of the approval letter
`and confirm receipt by phone.
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`3.
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`Within one business day of receipt confirmation:
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`a. Send an e-mail to the Approvals Distribution List (APPROVALS:) that
`contains the following information:
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`ANDA number
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`drug name (generic and trade name)
`applicant name
`approval or tentative approval date
`possible effective date for a tentative approval
`dosage form
`strength
`Rx or OTC
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`b. Transmit the dated approval letter to the secured shared area
`(\\cdfda\drugapp) in the same fashion, using the same naming conventions, as
`ORM project management staff.
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`4.
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`Ensure the confidentiality and useability of the secured computer shared area
`(\\cdfda\drugapp) by promptly notifying OIT staff of any personnel changes
`that need to be made to permissions because of incoming or departing project
`managers and consumer safety officers.
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`Freedom of Information (FOI) staff:
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`1.
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`Within one business day of availability on the shared area (electronic
`transmittal) or receipt from the review divisions (when documents are
`transmitted directly to FOI):
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`a. Redact approval letters and post the letters and, if applicable, the approved
`labeling text or FPL to the shared directory <\\cdfda\foiread\approvals>.
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`b. Alert, via e—mail, the Webmaster and the Drug Information Branch that
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`Originator: Director, Office of Training and Communications
`3/25/98
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`MAPP 4520.1
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`redacted material is available in the shared directory for posting to the Internet
`and Fax—on-Demand.
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`Maintain the secured shared area (\\cdfda\drugapp) by periodically removing
`outdated material.
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`Webmaster:
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`Within one business day of alerting by FOI staff, convert the redacted approval
`letters and, if applicable, the final approved labeling text or FPL to web
`forrnat(s) and post them to CDER’s Web Page.
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`Periodically remove outdated material from the shared area
`<\\cdfda\foiread\appr0vals>.
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`Drug Information Branch/Division of Communications Management/OTCOM staff:
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`Each business-day morning, copy redacted material from the redacted approvals
`directory <\\cdfda\f0iread\approvals> to CDER’s Fax-on-Demand system by
`10:00 a.m.
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`2.
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`Maintain and update the Approvals Distribution List (APPROVALS:).
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`EFFECTIVE DATE
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`This MAPP is effective upon date of publication.
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`Originator: Director, Office of Training and Communications
`3/25/98
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