> ## Documentation Index > Fetch the complete documentation index at: https://docs.pav.bio/llms.txt > Use this file to discover all available pages before exploring further. # List and search FDA records > FDA regulatory records with the applicant, sponsor or recipient linked to a Pav company where possible: Orange Book products, listed patents and exclusivities; Purple Book biologic products; orphan drug designations; warning letters; and drug/device recalls. Orange and Purple Book rows are the current monthly edition; warning letters and recalls are the published feed. Every filter is optional and filters combine with AND. `q` is a case-insensitive substring of the title, description, company name, FDA organization name, or FDA identifier; it does not match synonyms. `company_id` returns only records linked to that company, so an unlinked record (common for warning letters and recalls) never matches it; search the FDA name with `q` as well. Dates: `date_field=document_date` (default) filters on the date FDA issued the record; exclusivities have no issue date, so use `date_field=event_date` for expiries (patent, exclusivity), e.g. `record_type=orange_book_patent&date_field=event_date&date_from=2027-01-01&sort=event_date&direction=asc`. ## OpenAPI ````yaml /openapi.json get /v1/fda openapi: 3.1.0 info: title: Pav Enterprise API description: >- Read-only `/v1` API over Pav's biopharma dataset: drug programs, companies, clinical trials, deals, patent families, FDA records, a change feed, and dataset stats. Authenticate every request with a Pav API key as a bearer token: `Authorization: Bearer `. Mint a key in [Pav developer settings](https://app.pav.bio/settings/developer). All endpoints are `GET` and return JSON. List endpoints return a `{ data, pagination }` envelope. Pass `q=` to run relevance-ranked search that matches meaning as well as exact words; omit it for a filtered, paginated listing. Errors return `{ error: { code, message, request_id } }`. version: 1.2.0 servers: - url: https://api.pav.bio description: Production - url: / description: This server security: [] tags: - name: programs description: >- Search and filter drug pipeline assets by company, indication, target, modality, phase, or free text. Includes get-by-id, similar-programs, and facet autocomplete. - name: companies description: >- Tracked biopharma companies and their pipeline ownership. List a company's programs and change history. - name: trials description: >- Search clinical trials — ClinicalTrials.gov records plus Pav program/company links. Relevance-ranked search when `q=` is set; filtered browse otherwise. - name: deals description: >- Biopharma deals (M&A, licensing, collaborations, options, joint ventures) from SEC filings and press releases, with lifecycle state, headline economics, and source documents. - name: patents description: >- US patent families from USPTO with owners linked to Pav companies, member applications, ownership history, and statutory term. - name: fda description: >- FDA records with applicants linked to Pav companies: Orange Book products, patents and exclusivities, Purple Book biologics, orphan designations, warning letters, and recalls. - name: changes description: >- Detected pipeline movement events per company — added and removed assets and phase changes — with before/after phase and detection time. - name: stats description: High-level dataset counts and facet coverage. paths: /v1/fda: get: tags: - fda summary: List and search FDA records description: >- FDA regulatory records with the applicant, sponsor or recipient linked to a Pav company where possible: Orange Book products, listed patents and exclusivities; Purple Book biologic products; orphan drug designations; warning letters; and drug/device recalls. Orange and Purple Book rows are the current monthly edition; warning letters and recalls are the published feed. Every filter is optional and filters combine with AND. `q` is a case-insensitive substring of the title, description, company name, FDA organization name, or FDA identifier; it does not match synonyms. `company_id` returns only records linked to that company, so an unlinked record (common for warning letters and recalls) never matches it; search the FDA name with `q` as well. Dates: `date_field=document_date` (default) filters on the date FDA issued the record; exclusivities have no issue date, so use `date_field=event_date` for expiries (patent, exclusivity), e.g. `record_type=orange_book_patent&date_field=event_date&date_from=2027-01-01&sort=event_date&direction=asc`. operationId: list_fda_records parameters: - name: q in: query required: false schema: anyOf: - type: string maxLength: 200 - type: 'null' description: Substring of title, description, company or FDA identifier. examples: - semaglutide title: Q description: Substring of title, description, company or FDA identifier. - name: company_id in: query required: false schema: anyOf: - type: array items: type: integer - type: 'null' description: Records linked to any of these Pav company ids. Repeatable. title: Company Id description: Records linked to any of these Pav company ids. Repeatable. - name: record_type in: query required: false schema: anyOf: - type: array items: enum: - orange_book_product - orange_book_patent - orange_book_exclusivity - purple_book_product - orphan_designation - warning_letter - recall type: string - type: 'null' description: Restrict to these record types. Repeatable. examples: - recall title: Record Type description: Restrict to these record types. Repeatable. - name: application_key in: query required: false schema: anyOf: - type: string maxLength: 32 - type: 'null' description: Exact FDA application, e.g. `N:209637` (NDA) or `BLA:761508`. examples: - N:209637 title: Application Key description: Exact FDA application, e.g. `N:209637` (NDA) or `BLA:761508`. - name: product_key in: query required: false schema: anyOf: - type: string maxLength: 40 - type: 'null' description: Exact application + product, e.g. `N:209637:001`. title: Product Key description: Exact application + product, e.g. `N:209637:001`. - name: patent_number in: query required: false schema: anyOf: - type: string maxLength: 20 - type: 'null' description: Exact Orange Book listed patent number. title: Patent Number description: Exact Orange Book listed patent number. - name: designation_id in: query required: false schema: anyOf: - type: string maxLength: 20 - type: 'null' description: Exact OOPD orphan designation id. title: Designation Id description: Exact OOPD orphan designation id. - name: date_field in: query required: false schema: enum: - document_date - event_date type: string description: 'Which date `date_from` / `date_to` filter: issue or event date.' default: document_date title: Date Field description: 'Which date `date_from` / `date_to` filter: issue or event date.' - name: date_from in: query required: false schema: anyOf: - type: string format: date - type: 'null' description: On or after this date (inclusive). title: Date From description: On or after this date (inclusive). - name: date_to in: query required: false schema: anyOf: - type: string format: date - type: 'null' description: On or before this date (inclusive). title: Date To description: On or before this date (inclusive). - name: sort in: query required: false schema: enum: - document_date - event_date type: string description: '`document_date` (default) or `event_date`; nulls sort last.' default: document_date title: Sort description: '`document_date` (default) or `event_date`; nulls sort last.' - name: direction in: query required: false schema: enum: - asc - desc type: string description: '`desc` (default, newest first) or `asc`.' default: desc title: Direction description: '`desc` (default, newest first) or `asc`.' - name: limit in: query required: false schema: type: integer maximum: 100 minimum: 1 description: Rows per page (1-100). default: 25 title: Limit description: Rows per page (1-100). - name: offset in: query required: false schema: type: integer maximum: 100000 minimum: 0 description: Zero-based row offset for paging. default: 0 title: Offset description: Zero-based row offset for paging. - name: include_total in: query required: false schema: type: boolean description: Compute the exact total match count. default: false title: Include Total description: Compute the exact total match count. responses: '200': description: Successful Response content: application/json: schema: $ref: '#/components/schemas/FdaListResponse' '401': description: Missing or invalid API key (`unauthorized`). content: application/json: schema: $ref: '#/components/schemas/ErrorEnvelope' '404': description: Unknown id or route (`not_found`). content: application/json: schema: $ref: '#/components/schemas/ErrorEnvelope' '422': description: Invalid parameter (`validation_error`). content: application/json: schema: $ref: '#/components/schemas/ErrorEnvelope' '429': description: Rate limit exceeded (`rate_limited`); honor `Retry-After`. content: application/json: schema: $ref: '#/components/schemas/ErrorEnvelope' security: - EnterpriseApiKey: [] components: schemas: FdaListResponse: properties: data: items: $ref: '#/components/schemas/FdaRecord' type: array title: Data description: Page of FDA records. pagination: $ref: '#/components/schemas/Pagination' description: Pagination metadata for this page. type: object required: - data - pagination title: FdaListResponse ErrorEnvelope: properties: error: $ref: '#/components/schemas/ErrorBody' description: Error detail. Present only on 4xx/5xx responses. required: - error title: ErrorEnvelope type: object FdaRecord: properties: record_key: type: string title: Record Key description: >- Pav key for this record in the current FDA edition; pass it to `GET /v1/fda/{record_key}`. Orange Book, Purple Book and orphan designation keys include the edition, so they change when FDA publishes a new one. For a durable handle filter by `application_key`, `product_key`, `patent_number` or `designation_id`. examples: - purple_book_product:2026-08:761508:001 record_type: type: string enum: - orange_book_product - orange_book_patent - orange_book_exclusivity - purple_book_product - orphan_designation - warning_letter - recall title: Record Type description: Kind of FDA record. examples: - purple_book_product source: type: string title: Source description: FDA publication the record comes from. examples: - purple_book source_version: anyOf: - type: string - type: 'null' title: Source Version description: >- Source edition: `YYYY-MM` for Orange and Purple Book, the load date for orphan designations, null for warning letters and recalls (published continuously). examples: - 2026-08 fda_organization_name: anyOf: - type: string - type: 'null' title: Fda Organization Name description: Applicant, sponsor or recipient name as FDA spells it. examples: - Regeneron Pharmaceuticals, Inc. company: anyOf: - $ref: '#/components/schemas/FdaCompany' - type: 'null' description: >- The Pav company this FDA organization is linked to. Null when unlinked: most Orange Book, Purple Book and orphan records are linked; most warning-letter and recall recipients (compounders, device and food makers) do not. application_key: anyOf: - type: string - type: 'null' title: Application Key description: 'FDA application: `N:` (NDA), `A:` (ANDA) or `BLA:` plus the number.' examples: - BLA:761508 product_key: anyOf: - type: string - type: 'null' title: Product Key description: Application plus the FDA product number. examples: - BLA:761508:001 designation_id: anyOf: - type: string - type: 'null' title: Designation Id description: OOPD orphan designation id. examples: - '1186826' patent_number: anyOf: - type: string - type: 'null' title: Patent Number description: Orange Book listed US patent number. examples: - '10022461' title: type: string title: Title description: >- Display title: trade name, patent or exclusivity label, subject, or brand. examples: - GENGLYCOS description: anyOf: - type: string - type: 'null' title: Description description: >- Ingredient or proper name for products, patents and exclusivities; the designated indication for orphan designations; the subject for warning letters; the product for recalls. document_date: anyOf: - type: string format: date - type: 'null' title: Document Date description: >- Date FDA issued the record: approval, patent submission, designation, letter issue, or recall. Always null for exclusivities; null for some old products. event_date: anyOf: - type: string format: date - type: 'null' title: Event Date description: The date `event_date_type` names, e.g. a patent expiry. event_date_type: anyOf: - type: string - type: 'null' title: Event Date Type description: >- Meaning of `event_date`: `approval`, `patent_expiry`, `exclusivity_expiry`, `designation`, `issued`, `posted`, or `recall`. examples: - patent_expiry status: anyOf: - type: string - type: 'null' title: Status description: >- Source status: marketing status for products (`RX`, `OTC`, `DISCN`, ...), `listed`/`delisted` for patents, the exclusivity code for exclusivities, the designation status, `issued`/`closed` for warning letters, `active`/`terminated` for recalls. examples: - RX source_url: anyOf: - type: string - type: 'null' title: Source Url description: >- Official FDA page for the record. Null for Orange and Purple Book rows. details: $ref: '#/components/schemas/FdaRecordDetails' description: Record-type specific source fields. type: object required: - record_key - record_type - source - title title: FdaRecord Pagination: properties: limit: type: integer title: Limit description: Maximum number of rows returned for this request. examples: - 100 offset: type: integer title: Offset description: Zero-based row offset applied before returning results. examples: - 0 total: anyOf: - type: integer - type: 'null' title: Total description: >- Total matching rows across all pages. Null on relevance-ranked search responses and on listings requested without `include_total`. examples: - 590355 type: object required: - limit - offset title: Pagination ErrorBody: properties: code: description: >- Stable, machine-readable error code (e.g. `unauthorized`, `not_found`, `validation_error`, `error`). examples: - not_found title: Code type: string message: description: Human-readable explanation of the error. examples: - program 999999 not found title: Message type: string request_id: anyOf: - type: string - type: 'null' default: null description: >- Correlation id echoed in the `X-Request-ID` response header. Quote it when contacting Pav support about a failed request. examples: - 3f2b9c1d8a7e4f6b9c0d1e2f3a4b5c6d title: Request Id required: - code - message title: ErrorBody type: object FdaCompany: properties: company_id: type: integer title: Company Id description: Durable Pav company identifier. examples: - 5093 short_name: type: string title: Short Name description: Company slug. examples: - regeneron name: type: string title: Name description: Company display name. examples: - Regeneron Pharmaceuticals type: object required: - company_id - short_name - name title: FdaCompany FdaRecordDetails: properties: ingredient: anyOf: - type: string - type: 'null' title: Ingredient description: Orange Book active ingredient(s) as FDA lists them. examples: - SEMAGLUTIDE strength: anyOf: - type: string - type: 'null' title: Strength description: Orange Book / Purple Book strength. examples: - 300MG/5ML (60MG/ML) dosage_route: anyOf: - type: string - type: 'null' title: Dosage Route description: Orange Book dosage form and route, `FORM;ROUTE`. examples: - TABLET;ORAL dosage_form: anyOf: - type: string - type: 'null' title: Dosage Form description: Purple Book dosage form. examples: - Injection route: anyOf: - type: string - type: 'null' title: Route description: Purple Book route of administration. examples: - Intravenous therapeutic_equivalence_code: anyOf: - type: string - type: 'null' title: Therapeutic Equivalence Code description: >- Orange Book therapeutic-equivalence (TE) code; set only for multisource products. examples: - AB1 reference_listed_drug: anyOf: - type: boolean - type: 'null' title: Reference Listed Drug description: 'Orange Book: the product is a reference listed drug (RLD).' reference_standard: anyOf: - type: boolean - type: 'null' title: Reference Standard description: 'Orange Book: the product is the reference standard (RS).' patent_use_code: anyOf: - type: string - type: 'null' title: Patent Use Code description: Orange Book patent use code (method-of-use claim), when listed. examples: - U-4597 pediatric_extension: anyOf: - type: boolean - type: 'null' title: Pediatric Extension description: 'Orange Book patent: the expiry includes pediatric exclusivity.' drug_substance_claim: anyOf: - type: boolean - type: 'null' title: Drug Substance Claim description: Orange Book patent claims the drug substance. Null when not flagged. drug_product_claim: anyOf: - type: boolean - type: 'null' title: Drug Product Claim description: Orange Book patent claims the drug product. Null when not flagged. license_type: anyOf: - type: string - type: 'null' title: License Type description: >- Purple Book pathway: `351(a)` (reference product) or `351(k)` (biosimilar). examples: - 351(a) licensure: anyOf: - type: string - type: 'null' title: Licensure description: Purple Book licensure status. examples: - Licensed license_number: anyOf: - type: string - type: 'null' title: License Number description: Purple Book US license number of the holder. examples: - '1760' orphan_exclusivity_expiry: anyOf: - type: string format: date - type: 'null' title: Orphan Exclusivity Expiry description: Purple Book orphan exclusivity expiry. reference_product_exclusivity_expiry: anyOf: - type: string format: date - type: 'null' title: Reference Product Exclusivity Expiry description: Purple Book 12-year reference product exclusivity expiry. generic_name: anyOf: - type: string - type: 'null' title: Generic Name description: 'Orphan designation: generic name as the sponsor filed it.' examples: - inosine pranobex marketing_approval_date: anyOf: - type: string format: date - type: 'null' title: Marketing Approval Date description: 'Orphan designation: marketing approval date, once approved.' exclusivity_end_date: anyOf: - type: string format: date - type: 'null' title: Exclusivity End Date description: 'Orphan designation: orphan exclusivity end date.' approved_labeled_indication: anyOf: - type: string - type: 'null' title: Approved Labeled Indication description: 'Orphan designation: the approved labeled indication.' protected_indication: anyOf: - type: string - type: 'null' title: Protected Indication description: 'Orphan designation: the exclusivity-protected indication.' reason: anyOf: - type: string - type: 'null' title: Reason description: Recall reason category. examples: - Mislabeling reason_description: anyOf: - type: string - type: 'null' title: Reason Description description: Recall reason as FDA describes it. product_types: anyOf: - items: type: string type: array - type: 'null' title: Product Types description: Recall product types. Food-only recalls are excluded from this feed. examples: - - Drugs issuing_office: anyOf: - type: string - type: 'null' title: Issuing Office description: Warning letter issuing office. examples: - Center for Drug Evaluation and Research (CDER) fda_reference_id: anyOf: - type: string - type: 'null' title: Fda Reference Id description: Warning letter FDA reference number. examples: - '738238' closeout_date: anyOf: - type: string format: date - type: 'null' title: Closeout Date description: Warning letter close-out date, once FDA closed it out. type: object title: FdaRecordDetails description: >- Source fields for one record. Each field applies to the record types named in it. securitySchemes: EnterpriseApiKey: type: http description: >- Use a personal or organization Pav API key from Pav developer settings. Send it as Authorization: Bearer . scheme: bearer bearerFormat: Pav API key ````