`
` MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
`
`
`
`
`
`MAPP 4520.1 Rev.2
`
`
`POLICY
`
`
`OFFICE OF COMMUNICATIONS
`
`
`Communicating Drug Approval Information1
`
`
`
`
`Table of Contents
`
`PURPOSE ...........................................................................1
`
` 
`BACKGROUND ................................................................1
`
` 
`POLICY ..............................................................................2
`
` 
`REFERENCES ...................................................................3
`
` 
`RESPONSIBILITIES ........................................................3
`
` 
`DEFINITIONS ...................................................................7
`
` 
`EFFECTIVE DATE ...........................................................8
`
` 
`
`CHANGE CONTROL TABLE .........................................8
`
` 
`
`
`ATTACHMENT 1: Procedure for Publishing Approval
`
` Information for Original NDAs and BLAs.......................9
` 
`ATTACHMENT 2: Procedure for Publishing Approval
`Information for NDA/BLA Efficacy Supplements,
`NDA/BLA Labeling Supplements and Original ANDAs10
` 
`
`
`
`
`
`
`
` PURPOSE
`
`
`
`This MAPP establishes procedures for clearing and publishing new drug application (NDA),
`biologic license application (BLA), and abbreviated new drug application (ANDA) approval
`information on CDER’s Web site.
`
`
`
`BACKGROUND
`
`The approval or tentative approval of drug applications is of interest both inside and outside
`of FDA. FDA district offices, the trade press, the pharmaceutical industry, individual
`practitioners, patients, and international FDA counterparts are interested in this information.
`When an application is approved, FDA makes the information available according to the
`priorities and time periods specified in this MAPP.
`
`
`
` 1 Communicating Drug Approval Information refers to approved drug and biologic applications managed by
`
`CDER.
`
`
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
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`Almirall EXHIBIT 2067
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`Amneal v. Almirall
`IPR2019-00207
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`

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` MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
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`
`
`
`
`
`
`POLICY
`
`MAPP 4520.1 Rev.2
`
`
`
`
`
`
`
`1. Approval and tentative approval letters for original and supplemental drug
`applications will be made available via CDER’s Web site, generally within three
`business days of the approval, for the following categories:
`
`1) Original NDAs and BLAs
`
`2) NDA and BLA efficacy supplements
`
`3) NDA and BLA labeling supplements
`
`4) ANDAs identified by the Office of Generic Drugs (OGD)
`
`
`
`2. Approved labeling for drug approvals, but not for tentatively approved applications,
`
` will be made available on CDER’s Web, generally site within two business days of
`approval, for the following categories:
`
`1) Original NDAs and BLAs
`
`2) NDA and BLA efficacy supplements
`
`3) NDA and BLA labeling supplements
`
`4) ANDA products designated as the reference listed drug (RLD)
`
`
`3. Approved risk evaluation and mitigation strategy (REMS) (i.e., the enclosure to the
`approval letter) will be made available on CDER’s Web site, generally within three
`business days of approval, for the following categories:
`
`1) NDA and BLA products
`
`2) ANDA products designated as the RLD or as requested
`
`3) Shared system REMS that may include multiple NDAs and/or ANDAs (one
`copy)
`
`
`
`4. Action packages for approved original NDAs, BLAs, and efficacy supplements will
`be made available on CDER’s Web site after they are processed by the Division of
`Information Disclosure Policy (DIDP) based on the following redaction prioritization
`scheme2:
`Redaction Priority 1: New molecular entity (NME) NDA and original BLA
`
`(signed by the Office Director) action packages
`Redaction Priority 2: NDAs (non-NME), original BLAs (can be approved by the
`Division Director), and efficacy supplements subject to Section 505(l)(2)(A)(ii)
`of the Federal Food, Drug, and Cosmetic Act
`Redaction Priority 3: NDA and BLA action packages for original approvals, not
`covered in Redaction Priority 1 or 2
`
`
`
`5. Action packages or the equivalent for approvals not identified in the redaction
`prioritization scheme above, such as NDAs approved before 1998, ANDAs,
`chemistry supplements, and labeling supplements, are published on CDER’s Web site
`
`
` 2 The prioritization scheme applies to approvals after December 31, 1997 (Priorities 1 and 3) or September 27,
`
`
` 2007 (Priority 2).
`
`
`
`
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
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` MANUAL OF POLICIES AND PROCEDURES
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`
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`
`
`
`MAPP 4520.1 Rev.2
`
`
`after the information is processed by the Division of Information Disclosure Policy
`(DIDP) to respond to Freedom of Information Act (FOI) requests.
`
`
`
`
`
`REFERENCES
`
`
`1. Federal Food, Drug, and Cosmetic Act
`
`2. Freedom of Information Act (FOIA), 1966
`
`3. Americans With Disabilities Act (ADA), 1990, Section 508
`
`4. 21 U.S.C. § 355
`
`5. 21 CFR 314.105, Drugs
`
`6. 21 CFR 601.4, Biologics
`
`7. 21 CFR 314.3, Drugs
`
`8. 21 CFR 314.3 (b), Definitions
`
`9. FDA, 2002, Center for Drug Evaluation and Research, MAPP 6020.8: Action
`Packages for NDAs and Efficacy Supplements
`
`10. Rehabilitation Act of 1973 (29 U.S.C. § 701)
`
`
`
`
` RESPONSIBILITIES
`
`
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`
`
`
`
`
`
`Office of New Drugs (OND) regulatory project manager (RPM) assigned to the NDA or
`
` BLA:
`
`
`
`1. Check the approval or tentative approval letter with any enclosures (e.g., final agreed
`upon labeling text, REMS) into the electronic archive.
`
`
`2. Ensure a copy of the signed approval or tentative approval letter, with any enclosures,
`is promptly sent via a rapid form of communication, such as fax or secure email, to
`
` the applicant’s official regulatory contact. Confirm applicant receipt of the letter.
`
`
`3. If a press communication has been prepared, the RPM will notify the press office as
`soon as receipt of the approval letter has been confirmed by the applicant.
`
`
`4. Within one business day of approval, the RPM will issue an e-mail to the CDER-
`APPROVALS distribution list to notify personnel of the approval. If the application
`is for a NME or original BLA, the RPM should include the Center Director on the e-
`mail. The e-mail should include the following information:
`
`- NDA/BLA/supplement number
`
`
`Product names (proprietary and established/proper names)
`-
`
`
`- Applicant (not agent) name
`
`- Approval date
`
`- Chemical, review priority, and any other application classification codes
`
`-
`Indications
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
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` MANUAL OF POLICIES AND PROCEDURES
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`MAPP 4520.1 Rev.2
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`
`
`- Route(s) of administration
`
`
`- Rx or OTC
`
`
`The RPM should attach to the email the action letter with its enclosures and the
`Summary Review(s). Note: an email to CDER-APPROVALS does not need to be
`sent for tentative approvals. If division management requests that the Summary
`Review(s) be published shortly after approval (e.g., high profile approvals), contact
`Office of Regulatory Policy, Division of Information Disclosure Policy (DIDP)
`
`approximately 3 days before the planned approval date.
`
`
`5. Send an email notification to the Document Room at CDER-DRTL-ALL within one
`business day of the application approval. Attach a copy of the email to the outside
`cover of the action package. The email should include the following:
`
`
`1) Application number
`
`2) NME/original BLA Office Director Signature or non-NME/original BLA
`Division Director Signature
`
`3) Number of action package volumes and thickness in inches (e.g., 3 x 4”
`binders)
`
`4) Whether the pages are printed single or double-sided
`
`
`
`
`
`
`
`
`6. Within two business days of the application approval, deliver the completed action
`
`package to the reception area of the document room for scanning.
`
`Office of Generic Drugs project manager (PM) assigned to the ANDA:
`
`
`1. Check the approval or tentative approval letter with any enclosures, such as labeling
`or REMS, into the electronic archive.
`
`
`2. Ensure a copy of the signed approval or tentative approval letter for an original
`ANDA, with any enclosures, is promptly sent via a rapid form of communication,
`such as fax or secure email, to the applicant’s official regulatory contact. Confirm
`
`applicant receipt of the letter.
`
`
`
`
`3. For original ANDA approvals, send an email containing the following to the
`distribution list CDER-OGDAPPROVALS within one business day of receiving
`letter receipt confirmation:
`
`
`1) ANDA number
`
`
`2) Proprietary name (if there is one, as it would appear in the Orange Book)
`
`
`3) Established name
`
`
`
`4) Reference Listed Drug (RLD)
`
`
`
`5) Applicant name
`
`
`
`6) Approval or tentative approval date (if tentative, make bold)
`
`
`7) Indication(s)
`
`
`8) Dosage form
`
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
`
`
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` MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`
`
`
`MAPP 4520.1 Rev.2
`
`
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`
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`9) Strength(s)
`
`
`10) Rx or OTC marketing status
`
`
`
`
`
`4. For those original ANDA approval or tentative approval letters to be published on
`CDER’s web site within three business days of approval, add “PRIORITY
`APPROVAL” to the subject line of the email sent to the distribution list CDER-
`OGDAPPROVALS. Attach a copy of the letter and any enclosures, such as approved
`labeling or REMS. Specify if any of the enclosures to an approval letter are to be
`
`published on CDER’s Web site.
`
`
`5. Send an email to DIDP and the Division of Online Communication (DOC) to make a
`special request that supplemental ANDA approval letters or enclosures such as RLD
`labeling, or RLD REMS be published on the Internet. The requesting email should
`
`include a copy of the approval letter and any enclosures.
`
`
`Office of Business Informatics, Division of Data Management Services and Solutions,
`Document Management Services:
`
`
`
`
`1. For action packages (NDA and BLA approvals only):
`
`
` Within three business days of an approval for new molecular entities
`
`(NME)/original BLAs signed by the Office Director, or
`
`
` Within five business days of an approval for non-NMEs/original BLAs signed by
`the Division Director:
`
`1) Notify the OND RPM and DIDP that the action package has been received.
`
`2) Process action packages according to standard Document Processing Manual
`procedures. Scan the action package and insert the Portable Document
`Format (PDF) bookmarks.
`
`3) Electronically archive the scanned action package. Upload the scanned action
`package into the electronic archive.
`
`4) Send an email to the OND RPM and DIDP to inform them the scanning and
`archiving process is complete after the documents have been uploaded and the
`original action package is available for the RPM to pick-up from the
`document room.
`
`
`Office of Regulatory Policy, Division of Information Disclosure Policy (DIDP):
`
`
`1. Perform a disclosure review of the letter and enclosures and deliver the redacted
`information to the Division of Online Communications (DOC) within two business
`days of approval or tentative approval.
`
` Ensure all letters are in a format that will facilitate compliance with Section
`508 of the Rehabilitation Act of 1973.
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
`
`
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` MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
`
`
`
`
`
`MAPP 4520.1 Rev.2
`
`
`
`
`
` Save the redacted letter in the shared directory, using the DIDP established
`file-naming convention for DOC retrieval.
`
`
`2. When OND division management requests early publication of the summary review,
`perform a disclosure review of the summary review and save the redacted summary
`review in the DIDP and DOC shared directory using the DIDP established file-
`naming convention, for DOC retrieval.
`
`3. Perform a disclosure review of the action package consistent with the established
`redaction prioritization scheme. Save the redacted action package in the shared
`directory, shared with the DOC.
`
`
`
`
`
`
`
`Save the redacted action package into PDF format in files based on the
`CDER’s Web site display design using the DIDP established file-naming
`convention. Ensure each individual file does not exceed the size limit set by
`DOC.
`
`
`Save the multiple files that constitute the redacted action package in
`the appropriate priority folder located in the shared directory for DOC.
`
`
`Office of Communications, Division of Online Communications:
`
`
`
`1. Enter the basic approval information into CDER’s Web site, no sooner than one
`business day but within three business days for all approvals.
`
`
`2. Retrieve the signed approval letter from the electronic archive for OND approvals no
`sooner than one business day but within three business days of approval. Extract the
`approved labeling text that needs no disclosure review by DIDP from the approval
`letter. Convert the labeling to Web format. Publish the label on CDER’s Web site.
`Make the appropriate links from CDER’s Web site. By request, the labeling can be
`published on approval day if receipt of the approval letter has been confirmed by the
`RPM.
`
`
`3. Convert to a format in compliance with Section 508 and publish on CDER’s Web
`site, upon receipt from DIDP, the redacted approval letter and any enclosures or
`tentative approval letter no sooner than one business day but within three business
`days of approval. Make the appropriate links in CDER’s Web site. By request,
`publishing the letter on approval day can occur if receipt of the applicant’s letter is
`confirmed by the RPM.
`
`
`4. Convert the redacted summary review to a 508-compliant Web format and publish it
`on CDER’s Web site within two business days of receipt from DIDP.
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
`
`
`
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` MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
`
`
`
`
`
`MAPP 4520.1 Rev.2
`
`
`
`
`
`
`5. Convert the redacted action package reviews to Web format. Publish the action
`packages on CDER’s Web site according to the priority status of the action package.
`Make the appropriate links in CDER’s Web site within the following timeframes after
`receipt of the redacted action package from DIDP:
`
`
`
`
`1) Publication Priority 1: one business day
`
`
`2) Publication Priority 2: five business days
`
`
`3) Publication Priority 3: fifteen business days
`
`
`
`Office of Communications, Division of Drug Information:
`
`
`
`1. Maintain and update the distribution list CDER-APPROVALS.
`
`
`
`
`
`
`DEFINITIONS
`
`Action Package: A compilation of (1) FDA-generated documents related to the review of an
`NDA, BLA or efficacy supplement, (2) documents pertaining to the format and content of the
`application generated during drug development (Investigational New Drug (IND)), and (3)
`labeling submitted by the applicant.
`
`Applicant: Any person(s) who submits an application, abbreviated application, or
`supplemental application, to obtain FDA approval of a new drug. Any person who owns an
`approved new drug or abbreviated new drug application.
`
`Application: The vehicle to seek FDA approval for the sale and marketing of a drug product.
`
`Approval Letter: A letter to an applicant from FDA approving an application or an
`
`abbreviated application for marketing a drug product in the United States.
`
`Approvals Distribution List: Internal email system distribution lists, CDER-APPROVALS
`and CDER-OGDAPPROVALS directed to FDA individuals who require information about
`just-approved drug products. Lists include staff in the Division of Information Disclosure
`Policy and the Division of Online Communications.
`
`Approved Labeling: Final approved text and graphics of the prescribing information,
`generally limited to prescribing information and medication guide for prescription products.
`For non-prescription drug products, the approved labeling consists of the carton and
`immediate container labels.
`
`CDER Web site: A public Internet site maintained by CDER’s Division of Online
`Communication, containing information related to CDER’s mission.
`
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
`
`
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`
` MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
`
`
`
`
`
`MAPP 4520.1 Rev.2
`
`
`
`
`Division of Information Disclosure Policy (DIDP): CDER division responsible for
`reviewing and redacting information for release to the public.
`
`Enclosure: Information included with an approval letter that is not in the body of the
`letter, such as approved labeling and REMs.
`
`Orange Book: The common name for the list of Approved Drug Products with Therapeutic
`Equivalence Evaluations. Published on the FDA Web site since 1997, this document
`
`identifies drug products approved by the FDA on the basis of safety and effectiveness.
`
`Summary Review (21 U.S.C. § 355(l)(2)(C)(iv)): A review that “documents conclusions
`from all reviewing disciplines about the drug, noting any critical issues and disagreements
`with the applicant and within the review team and how they were resolved, recommendations
`for action, and an explanation of any non-concurrence with review conclusions.”
`
`Risk Evaluation Mitigation Strategy: Required risk management plans that use risk
`
`minimization strategies beyond the professional labeling to ensure that the benefits of
`certain prescription drugs outweigh their risks.
`
`
`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. The delayed effective date is generally
`because product marketing is blocked by a patent or marketing exclusivity. An approval
`with a delayed effective date does not become final until FDA issues an approval letter.
`
`
`
`
`
` EFFECTIVE DATE
`
`This MAPP is effective upon date of publication.
`
`
`
`
` CHANGE CONTROL TABLE
`
`
`Revisions
`
`n/a
`
`
` Scope of MAPP broadened to include BLAs and REMS
`
`  Updated all content, to reflect current practices
`
`
` Decreased the time for webmaster to post change from three to
`two business days, for approved labeling for drug approvals
`
`Revision
`Effective
`Number
`Date
`initial
`3/26/98
`8/20/14 Rev. 1
`
`7/14/17 Rev. 2
`
`
`
`
`
`
`
`Originating Office: Office of Communications
`
`
`Effective Date: 3/24/98; 8/20/14 / 7/14/17
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`MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`MAPP 4520.1 Rev.2
`
`ATTACHMENT 1: Procedure for Publishing Approval Information for Original NDAs and
`BLAs
`
`
`
`
`Office of New Drugs (0ND) Regulatory Project
`Manager (RPM) inputs approval letter with
`
`attachments into the electronic archive.
`
`—l
`0ND RPM promptly sends approval letter with
`
`attachments to applicant’s official regulatory contact
`and requests receipt confirmation. Once
`confirmation is received, notify press office, if press
`communications are planned.
`
`
`
`OND RPM sends approval email to CDER-Approvals
`
`
`distribution list within one business day of the
`approval.
`
`
`
`
`
`0ND RPM sends an email to the distribution list
`
`
`
`Division of Online Communications (DOC)
`receives auto-notification from electronic
`
`
`
`archive, and begins to enter initial approval
`
`
`and labeling information into Drugs@FDA.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Division of Disclosure Policy (DIDP) receives
`auto-notification from electronic archive
`
`
`and begins letter and attachment review.
`
`
`
`
`
`
`
`
`
`
`
`
`CDER-DRTL—ALL within one business day of approval,
`to indicate the action package will be delivered to
`the Division of Data Management Services and
`Solutions (the document room).
`
`
`
`
`0ND RPM delivers the action package to the
`document room (DR) within two business days of
`
`approval.
`l
`The DR notifies 0ND RPM and DIDP within two
`‘
`business days of when action package is received.
`
`The OR scans the package and enters it into the
`electronic archive.
`
`The DR sends an email to 0ND RPM, and DIDP
`notifying them that the action package has been
`entered into the electronic archive.
`
`
`The DR returns original action package to OND RPM.
`
`_l
`
`DIDP performs a disclosure review of the approval
`
`letter, the attachments, and the action package.
`
`DIDP places redacted files in the electronic directory
`
`shared with the DOC when they are ready for
`
`publication.
`
`
`DOC converts the redacted approval letter,
`
`
`attachments, and action package to a Web format
`
`and publishes it in Drugs@FDA.
`
`
`Originating Office: Office of Communications
`Effective Date: 334mg 8401-1-4/ 7/14/17
`
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`MANUAL OF POLICIES AND PROCEDURES
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`MAPP 4520.1 Rev.2
`
`ATTACHMENT 2: Procedure for Publishing Approval Information for NDAIBLA Efficacy
`Supplements, NDAIBLA Labeling Supplements and Original ANDAs
`
`Office of New Drugs (OMB) and Office of Generic Drugs
`(06 D) Regulatory Project Manager (RPM) inputs approval
`letter with attachments into the electronic archive.
`
`Division of Online Communications (DOC)
`receives auto-notification from electronic
`archive and begins to enter initial
`approval and labeling information into
`
`RPM promptly sends approval letter with attachments to
`
`applicant’s official regulatory contact and requests receipt
`
`confirmation. Once confirmation is received, notify press
`office, if press communications are planned.
`
`Division of DiSC|osure Policy (DIDP)
`receives autonotification from electronic
`archives and begins NDA / BLA letter and
`attachment review.
`
`Drugs@FDA.
`
`
`
`
`060 RPM sends an email to the distribution list CDER-
`OGDAPPROVALS, and 0ND RPM sends an email to CDER
`Approvals, and prepares action package, if required, as per
`CDER MAPPS 4520.1 and 6020.8.
`
`060 RPM adds ”PRIORITY APPROVAL" to the subject line of
`
`
`the email for letters to be published within three business
`
`
`days on the Web and will attach approval letter with any
`attachments.
`
`DlDP performs a disclosure review of the approval letter, the attachments, or
`the tentative approval letter and attachments. If requested under FOIA, the
`action package or the equivalent is reviewed according to established
`procedures/prioritization schemes. Redacted files are placed in the electronic
`directory shared with DOC when they are ready for publication.
`
`DOC converts the redacted approval letter, attachments,
`and action package, or the equivalent, to a Web format and
`publishes it in Drugs@FDA.
`
`Originating Office: Oflice of Communications
`Effective Date:m MOI-Ml 7/14/17
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