Obstetrics, Reproductive and Urologic Drugs Advisory Committee

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Stored: Obstetrics, Reproductive and Urologic Drugs Advisory Committee

Obstetrics, Reproductive and Urologic Drugs Advisory Committee
Type: Boards, Commissions, and Committees
Parent organization: Food and Drug Administration
Top organization: Department of Health and Human Services
Employees: 13
Executive: Chairperson
Budget: $336,686 (FY 2025 estimate)
Address: 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
Website: https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee
Creation Legislation:
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Obstetrics, Reproductive and Urologic Drugs Advisory Committee
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Mission
The Obstetrics, Reproductive and Urologic Drugs Advisory Committee advises the FDA on the safety and effectiveness of drugs for obstetrics, gynecology, urology, and related specialties to ensure safe and effective human drug products. It provides expert recommendations to the FDA Commissioner to support regulatory decision-making in these fields.
Services

Drug safety and efficacy reviews; regulatory advice; public meeting forums

Regulations


Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) is an FDA advisory committee established on March 23, 2022, succeeding the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), to evaluate human drug products for obstetrics, gynecology, urology, and related specialties, headquartered at the FDA’s White Oak Campus in Silver Spring, Maryland. Comprising 13 core voting members—experts in obstetrics, gynecology, urology, and related fields—ORUDAC meets 1-3 times annually to review data and provide non-binding recommendations on drug approvals, such as those for contraception or overactive bladder treatments, influencing FDA regulatory outcomes within the Center for Drug Evaluation and Research (CDER).

Official Site

Mission

The Obstetrics, Reproductive and Urologic Drugs Advisory Committee aims to ensure the safety and effectiveness of drugs in obstetrics, gynecology, and urology by providing the FDA with independent expert evaluations of clinical data and regulatory issues. It supports FDA’s public health mission by advising on drug approvals and policies, focusing exclusively on these specialties after osteoporosis and bone disease topics were transferred to another committee in 2022.[1]

Parent organization

The Obstetrics, Reproductive and Urologic Drugs Advisory Committee operates under the Food and Drug Administration, within the Center for Drug Evaluation and Research (CDER), part of the Department of Health and Human Services.[2]

Legislation

ORUDAC was established on March 23, 2022, under FDA authority (15 U.S.C. 1451 et seq.; 21 U.S.C. 321 et seq.) via a charter amendment renaming BRUDAC, governed by the Federal Advisory Committee Act of 1972, with its charter renewed biennially.[3]

Partners

ORUDAC collaborates with:

Number of employees

ORUDAC has 13 core voting members, including the Chairperson, appointed as experts; no full-time staff are employed, with support from FDA CDER personnel.[5]

Organization structure

ORUDAC is a flat advisory body:

  • Core Voting Members review data and provide recommendations.
  • Temporary Members join for specialized expertise as needed.

Leader

The Obstetrics, Reproductive and Urologic Drugs Advisory Committee is headed by a Chairperson, appointed by the FDA Commissioner or designee; the current chair is not specified in the latest roster as of February 2025.[6]

Divisions

ORUDAC has no formal divisions but organizes:

  • Ad Hoc Panels for specific drug reviews (e.g., future meetings post-2022).[7]

List of programs

ORUDAC supports:

Last total enacted budget

ORUDAC’s estimated annual cost for FY 2025 is $336,686, including $128,055 for member compensation/travel and $208,631 for 1.1 person-years of FDA staff support, per standard FDA committee budgeting.[9]

Staff

ORUDAC’s 13 voting members are appointed experts serving up to four-year terms, supported by a Designated Federal Officer and FDA staff (1.1 person-years); it employs no direct staff.[10]

Funding

ORUDAC is funded through the FDA budget within HHS appropriations, covering member expenses and staff support, consistent with other advisory committees.[11]

Services provided

ORUDAC reviews drug safety and efficacy data, advises on regulatory policies, and hosts public meetings to inform FDA decisions on obstetrics, gynecology, and urology drugs.[12]

Regulations overseen

ORUDAC does not oversee regulations but advises under FDA jurisdiction, including 21 CFR Part 14, governing advisory committees.[13]

Headquarters address

The headquarters address, as listed on Google Maps, is 10903 New Hampshire Ave, Silver Spring, MD 20993, USA, within the FDA White Oak Campus.

History

ORUDAC succeeded BRUDAC on March 23, 2022, per Federal Register notice 87 FR 16489, evolving from the Reproductive Health Drugs Advisory Committee (est. 1978) and BRUDAC (2010-2022), refocusing solely on obstetrics, gynecology, and urology after bone disease topics shifted elsewhere.[14]

External links

References

  1. ↑ "ORUDAC Overview". Food and Drug Administration. https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  2. ↑ "About Advisory Committees". Food and Drug Administration. https://www.fda.gov/advisory-committees/about-advisory-committees. 
  3. ↑ "ORUDAC Naming". Federal Register. March 23, 2022. https://www.federalregister.gov/documents/2022/03/23/2022-06100/advisory-committee-bone-reproductive-and-urologic-drugs-advisory-committee-change-of-name-and-function. 
  4. ↑ "ORUDAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/charter-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  5. ↑ "ORUDAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/charter-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  6. ↑ "ORUDAC Roster". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/roster-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  7. ↑ "ORUDAC Overview". Food and Drug Administration. https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  8. ↑ "ORUDAC Meeting Materials". Food and Drug Administration. https://www.fda.gov/advisory-committees/committees-and-meeting-materials/obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  9. ↑ "ORUDAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/charter-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  10. ↑ "ORUDAC Roster". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/roster-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  11. ↑ "ORUDAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/charter-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  12. ↑ "ORUDAC Overview". Food and Drug Administration. https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  13. ↑ "ORUDAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee/charter-obstetrics-reproductive-and-urologic-drugs-advisory-committee. 
  14. ↑ "ORUDAC Naming". Federal Register. March 23, 2022. https://www.federalregister.gov/documents/2022/03/23/2022-06100/advisory-committee-bone-reproductive-and-urologic-drugs-advisory-committee-change-of-name-and-function. 
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