premarket: Premarket

premarketR Documentation

Premarket

Description

FDA's Premarket Databases, assembled from fdadata::pmn and fdadata::pma.

Usage

premarket

Format

A tibble with 225279 rows and 30 fields:

submission_number

chr "N12159", "N61034", "N50100", "N50016", "…

sponsor

chr "ETHICON, INC.", "THE UPJOHN CO.", "PFIZE…

company_clean

chr "ETHICON", "THE UPJOHN", "PFIZER", "PFIZE…

company_group

chr "JOHNSON AND JOHNSON", "THE UPJOHN", "PFI…

contact

chr NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

address_line_1

chr "1000 Route 202", "7000 PORTAGE ROAD", "2…

address_line_2

chr NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

city

chr "Raritan", "KALAMAZOO", "NY", "NY", "NY",…

state

chr "NJ", "MI", "NY", "NY", "NY", "NY", "NY",…

country

chr "USA", "USA", "USA", "USA", "USA", "USA",…

zip_code

chr "08869", "49001", "10017", "10017", "1001…

date_start

date 1960-10-14, 1968-10-09, 1969-09-04, 1969…

date_decision

date 1960-10-14, 1968-10-09, 1969-09-04, 1969…

decision_code

chr "APPR", "APRL", "APRL", "APRL", "APRL", "…

panel_code

chr "SU", "MI", "MI", "MI", "MI", "MI", "MI",…

product_code

chr "LMG", "JTT", "JTT", "JTT", "JTT", "LON",…

summary

fct NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

track

fct NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

third_party_review

chr NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

expedited

fct Not Expedited, Not Expedited, Not Expedit…

device

chr "SURGICEL BRAND ABSORBABLE HEMOSTAT", "LI…

type

chr "PMA", "PMA", "PMA", "PMA", "PMA", "PMA",…

panel

fct "General & Plastic Surgery", "Microbiolog…

decision

fct Approved, Approved - Reclassified, Approv…

decision_category

fct Approved, Approved, Approved, Approved, A…

date_federal_register

date NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, …

generic_name

chr "Agent, absorbable hemostatic, non-collag…

reason

chr NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

docket_number

chr NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

approval_order_statement

chr NA, NA, NA, NA, NA, NA, NA, NA, NA, NA, N…

Details

Some additional processing is done to attempt to make more sense of the company names. fdadata::clean_company_names is used with thorough = FALSE to generate fdadata::premarket$company_clean. It is used with thorough = TRUE to generate fdadata::premarket$company_group. This attempts to consolidate submissions from some of the largest companies based on known acquisitions. See ?fdadata::company_clean().

Going from sponsor to company_clean reduces the number of unique company names from 39223 to 32068, a reduction of 7155 or approximately 18%.

company_group has 31016 unique company names – 1052 less that company_clean (roughly a 3% reduction) and 8207 less than sponsor – for a total reduction of about 21%.

Source

FDA's PMA database download file and 510(k) database download files accessed 2025-04-10.


bjoleary/fdadata documentation built on April 14, 2025, 6:02 p.m.