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  7. FAQs and Common Complaints
  1. CDER Ombuds

FAQs and Common Complaints

Section A: General

  1. Are there any time restrictions or rules for bringing an issue to the Ombuds?
    No. You can contact the Ombuds at any time. Keep in mind that your options for resolution might be constrained by statutory, regulatory, or administrative time frames.
  2. Do you get involved with cases in litigation?
    The Ombuds does not get involved in matters currently in litigation.
  3. When do you consider a case closed?
    The CDER Ombuds considers a case closed when no further action is needed to satisfy the complainant’s case and/or the complainant was referred to the appropriate groups outside of the Ombuds office for resolution. A case can also be considered closed if all options have been exhausted for the Ombuds office or if an action has taken place in which the CDER Ombuds cannot become involved (e.g. legal cases, formal EEO complaints).
  4. I have a question about requesting information from FDA.
    Some or all of the information that you seek might be readily available on our publicly available Electronic Reading Room and other locations. If you still want to request information from FDA/CDER, please follow the instructions; note that there might be a fee to process your request.
  5. Can an external person/group have a face-to-face meeting with the Ombuds?
    Although this is a somewhat rare occurrence, yes, any interested party can meet with the Ombuds. Most situations can be resolved by other means of communication; however, in certain circumstances, a face-to-face meeting might be warranted. The meeting must have a clear purpose.
  6. How do I submit a formal complaint to CDER?
    The CDER Ombuds does not accept formal complaints, either verbally or in writing. Please review the Dispute Resolution section of this website.
  7. Are there limits as to what the Ombuds can do for me?
    Yes. The Ombuds will NOT:
    • Overturn a decision/action, as the ombuds is not a deciding official
    • Force anyone to turn over or modify a decision/action
    • Take the position of advocate
    • Work on a case while the case is pending in a formal appeals process
    • Violate the Ombuds ethics and operating principles

    As spelled out by the American Bar Association, these are the limitations of a federal ombuds authority.

    “An Ombuds should not, nor should an entity expect or authorize an Ombuds to:

    (1) make, change or set aside a law, policy, or administrative decision

    (2) make binding decisions or determine rights

    (3) directly compel an entity or any person to implement the Ombuds’ recommendations

    (4) conduct an investigation that substitutes for administrative or judicial proceedings

    (5) accept jurisdiction over an issue that is currently pending in a legal forum unless all parties and the presiding officer in that action explicitly consent

    (6) address any issue arising under a collective bargaining agreement or which falls within the purview of any federal, state, or local labor or employment law, rule, or regulation, unless there is no collective bargaining representative and the employer specifically authorizes the ombuds to do so, or

    (7) act in a manner inconsistent with the grant of and limitations on the jurisdiction of the office when discharging the duties of the office of the Ombuds."

  8. Is there any circumstance in which the Ombuds would break confidentiality?
    Yes. The Ombuds must report any allegations of criminal activity to the Office of Internal Affairs or Office of Criminal Investigations, as appropriate. In these cases, the identity of the confidential source may be protected from public disclosure. The Ombuds will also break confidentiality if imminent risk of serious harm is evident.

Section B: Pharmaceutical Industry and Researchers

  • I want to market a product and I am not sure if FDA considers it a drug, device, or biologic. It might even be a combination of more than one. How do I find out which FDA Center will have regulatory jurisdiction?
    Read the applicable information at Office of Combination Products and then contact our Office of Combination Products at combination@fda.gov or call 301-796-8930.
  • I want to report a current or expected drug shortages.
    Please contact our Drug Shortages Program at drugshortages@cder.fda.gov.
  • Who should I ask about Drug Master Files?
    Email your question to DMFquestion@fda.hhs.gov.
  • I am aware of a protocol violation and want to report it to FDA.
    Please contact Dana Walters in the Office of Scientific Investigations at 301-796-3378 (email: >Dana.Walters@fda.hhs.gov) or contact the CDER Ombuds.
  • I submitted my application to Drug Registration and Listing and haven’t received a response yet. How should I follow up?
    The fastest and easiest way to get a response is to send an email to edrls@fda.hhs.gov, and if you get no response within two weeks, please contact the Ombuds.
  • How is the CDER Ombuds related to the FDA (Agency level) Ombuds?
    The role of the CDER Ombuds is similar to the FDA Ombuds and both Ombuds offices follow the same operating principles of confidentiality, informality, and neutrality. However, utilizing the CDER Ombuds provides a way for anyone with a complaint or dispute involving CDER entities or programs to work through their problem at a level closer to the source. The CDER Ombuds is in the Center Director's Office of Executive Programs.
  • I am unsatisfied with the outcome of my complaint to the CDER Ombuds, who should I contact?
    You can contact the Agency level Ombuds office at ombudsman@oc.fda.gov or call 301-796-8530.

Section C: Consumers, Healthcare Practitioners, Media, and General Public

  1. I have a question about a drug.
    CDER’s Division of Drug Information (DDI) responds to public questions about human drug products. You can email them at druginfo@fda.hhs.gov or call DDI at 301-796-3400. The FDA Information for Consumers web page might give you an answer to your question.
  2. I want to report a bad reaction to a drug.
    Our system for collecting this type of information is called MedWatch. If you want to report an adverse event, i.e. bad reaction to a drug, please voluntarily report it at Reporting Serious Problems to FDA or call 1-800-332-1088. If you had a life-threatening reaction to an FDA-regulated product you purchased from a Website, please contact your health care practitioner for advice and then call FDA at 866-300-4374 or 301-796-8240 to report the website.
  3. I have a complaint about a pharmacy.
    Please contact the State Board of Pharmacy for the state in which the pharmacy is located.
  4. I saw a drug for sale on the internet and I don’t think it can be legally sold on the internet.
    You can report it at Reporting Unlawful Sales of Medical Products on the Internet.
  5. I saw drug advertising that I believe is false, misleading, or lacks fair balance.
    If you are a consumer, please review the Prescription Drug Advertising web page and report it to our Office of Drug Marketing, Advertising, and Communications.

    If you are a healthcare professional, please participate in our Bad Ad program by reporting the violation to BadAd@fda.gov.

  6. I am a reporter and want to interview the ombuds.
    Please contact FDA’s Press Office.
  7. Where can I find information on safety alerts, enforcement actions, and get tips on buying medicines online?
    FDA posts updated information on this site, Protecting Yourself.
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