Dora HuangCHECK OUT OUR EXPERIENCE

Dora Huang

Intern

Originally From:
Houston, TX
About:

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

Fun Fact:
Dora is a huge fan of musical theater and Star Wars.
Recent Updates
FDA Rollouts Innovation and Improvements to Medical Device Sterilization
The FDA introduced a new, voluntary program “Ethylene Oxide Sterilization Master File Pilot Program” that accelerates the documentation processes for sterilization providers and device manufacturers.
February 2020
KNowledge Base Contributions
When should food-effect bioavailability (BA) and bioequivalence (BE) studies be conducted?
FREQUENTLY ASKED QUESTIONS
What information should be included in the summary of clinical study findings?
FREQUENTLY ASKED QUESTIONS
What information should be included in the description of a clinical study design?
FREQUENTLY ASKED QUESTIONS
What are the different endpoints for a clinical study?
FREQUENTLY ASKED QUESTIONS
What level of detail is necessary in describing a clinical study?
FREQUENTLY ASKED QUESTIONS
What types of clinical studies should be included in your FDA submission?
FREQUENTLY ASKED QUESTIONS
How do you submit a 510(k) using the safety and performance based pathway?
FREQUENTLY ASKED QUESTIONS
How do you prepare a 510(k) using the safety and performance based pathway?
FREQUENTLY ASKED QUESTIONS
What device types are appropriate for the safety and performance based pathway?
FREQUENTLY ASKED QUESTIONS
What devices does the FDA categorize as a SaMD, and how is clinical evaluation performed?
FREQUENTLY ASKED QUESTIONS
What will occur when an investigator is disqualified?
FREQUENTLY ASKED QUESTIONS
What is a Part 16 hearing?
FREQUENTLY ASKED QUESTIONS
What is a Notice of an Opportunity for Hearing?
FREQUENTLY ASKED QUESTIONS
What is a consent agreement?
FREQUENTLY ASKED QUESTIONS
What is a NIDPOE?
FREQUENTLY ASKED QUESTIONS
What supporting information is necessary for FDA acceptance of a foreign clinical studies not conducted under an IND?
FREQUENTLY ASKED QUESTIONS
What are the criteria for a waiver intended for foreign clinical studies not conducted under an IND?
FREQUENTLY ASKED QUESTIONS
When will waivers be needed for foreign clinical studies not conducted under an IND?
FREQUENTLY ASKED QUESTIONS
What does FDA consider an “adequately constituted” IEC?
FREQUENTLY ASKED QUESTIONS
Will FDA need access to case records maintained by the investigator or additional background data such as hospital or other institutional records?
FREQUENTLY ASKED QUESTIONS
Would a study report “Synopsis” provide a sufficiently detailed summary of the protocol and study results for FDA acceptance of foreign clinical studies not conducted under an IND?
FREQUENTLY ASKED QUESTIONS
Is the name and address of the research facility a sufficient description for supporting information intended for FDA acceptance of foreign clinical studies not conducted under an IND?
FREQUENTLY ASKED QUESTIONS
What documentation should the sponsor or applicant provide regarding investigator qualifications?
FREQUENTLY ASKED QUESTIONS
What types of studies are generally NOT exempt from IND regulations?
FREQUENTLY ASKED QUESTIONS
What types of studies are generally exempt from IND regulation?
FREQUENTLY ASKED QUESTIONS
What are the requirements that allow planned studies to be exempt from IND requirements?
FREQUENTLY ASKED QUESTIONS
How should the risk/benefit analysis be performed in the practice of oncology?
FREQUENTLY ASKED QUESTIONS
What will FDA lift a clinical hold that was imposed to protect subjects from investigator misconduct?
FREQUENTLY ASKED QUESTIONS
What steps will FDA take before imposing a clinical hold to protect subjects from investigator misconduct?
FREQUENTLY ASKED QUESTIONS
Under what circumstances would FDA consider imposing a clinical hold following discovery of clinical investigator misconduct?
FREQUENTLY ASKED QUESTIONS
What is a clinical hold?
FREQUENTLY ASKED QUESTIONS
How can FDA protect human subjects following the discovery of clinical investigator misconduct?
FREQUENTLY ASKED QUESTIONS
What actions can FDA take to address clinical investigator misconduct?
FREQUENTLY ASKED QUESTIONS
What are a clinical investigator's responsibilities?
FREQUENTLY ASKED QUESTIONS
What should IRBs do when reviewing the types of IVD studies that are the focus of this guidance?
FREQUENTLY ASKED QUESTIONS
Should sponsors consider anything else in deciding whether or not to conduct a study that may fall within the exercise of enforcement discretion?
FREQUENTLY ASKED QUESTIONS
What types of records should be kept for these types of studies?
FREQUENTLY ASKED QUESTIONS
In what circumstances does FDA intend to exercise enforcement discretion as to the requirements for informed consent for use of specimens in FDA regulated IVD studies?
FREQUENTLY ASKED QUESTIONS
What is a Group C treatment IND?
FREQUENTLY ASKED QUESTIONS
What is a treatment IND?
FREQUENTLY ASKED QUESTIONS
How should gender differences be factored into the clinical investigation process?
FREQUENTLY ASKED QUESTIONS
When can you receive exception from informed consent for planned emergency research?
FREQUENTLY ASKED QUESTIONS
When can you receive exception from informed consent requirements?
FREQUENTLY ASKED QUESTIONS
When can you receive emergency exemption from prospective IRB approval?
FREQUENTLY ASKED QUESTIONS
How can you obtain an emergency IND?
FREQUENTLY ASKED QUESTIONS
Are placebo-controlled studies effective?
FREQUENTLY ASKED QUESTIONS
What are active-control clinical trials?
FREQUENTLY ASKED QUESTIONS
What types of controls are used in clinical studies?
FREQUENTLY ASKED QUESTIONS
Does your software device qualify for the abbreviated 510(k) program?
FREQUENTLY ASKED QUESTIONS
Does your software device qualify for a special 510(k) submission?
FREQUENTLY ASKED QUESTIONS
How should unresolved anomalies, like bugs or defects, be documented?
FREQUENTLY ASKED QUESTIONS
What information should be included in the verification and validation documentation?
FREQUENTLY ASKED QUESTIONS
When is a software development environment description required?
FREQUENTLY ASKED QUESTIONS
What should be included in a traceability analysis?
FREQUENTLY ASKED QUESTIONS
What is an architecture design chart?
FREQUENTLY ASKED QUESTIONS
What should be documented in the software requirements specification?
FREQUENTLY ASKED QUESTIONS
What should be included in your device hazard analysis for a software device?
FREQUENTLY ASKED QUESTIONS
What should be included in your software description for your regulatory submission?
FREQUENTLY ASKED QUESTIONS
What is the documentation required for a software-related submission?
FREQUENTLY ASKED QUESTIONS
How can you determine the level of concern of your software device?
FREQUENTLY ASKED QUESTIONS
What are the qualifications for major, moderate, or minor levels of concern?
FREQUENTLY ASKED QUESTIONS
What can be categorized as a minor injury, and what can be considered a serious injury?
FREQUENTLY ASKED QUESTIONS
What does verification and validation of software devices consist of?
FREQUENTLY ASKED QUESTIONS
What content and review process are expected for an Informational Meeting?
FREQUENTLY ASKED QUESTIONS
What content and review process are expected for a Study Risk Determination Request?
FREQUENTLY ASKED QUESTIONS
What is the typical review process of a SIR?
FREQUENTLY ASKED QUESTIONS
What content is expected to be included within a Submission Issue Request (SIR)?
FREQUENTLY ASKED QUESTIONS
What is the typical review process of a Pre-Sub?
FREQUENTLY ASKED QUESTIONS
What content is expected to be included within a Pre-Submission?
FREQUENTLY ASKED QUESTIONS
What is the format of a Q-Submission meeting?
FREQUENTLY ASKED QUESTIONS
How will your Q-Submission be tracked by the FDA?
FREQUENTLY ASKED QUESTIONS
What information should be included in a Q-Submission?
FREQUENTLY ASKED QUESTIONS
How should you link your Q-Submission to future regulatory submissions?
FREQUENTLY ASKED QUESTIONS
What are some types of interactions that fall outside of the Q-Submission program?
FREQUENTLY ASKED QUESTIONS
What are some uses of the Informational Meeting Q-Submission program?
FREQUENTLY ASKED QUESTIONS
What are some other types of Q-Submissions?
FREQUENTLY ASKED QUESTIONS
What is an Informational Meeting?
FREQUENTLY ASKED QUESTIONS
What is a Study Risk Determination?
FREQUENTLY ASKED QUESTIONS
What is a Submission Issue Request (SIR)?
FREQUENTLY ASKED QUESTIONS
What is a Pre-Sub?
FREQUENTLY ASKED QUESTIONS
How do you design a reproducibility study?
FREQUENTLY ASKED QUESTIONS
What should be included in a binary qualitative test?
FREQUENTLY ASKED QUESTIONS
What should be included in a quantitative test?
FREQUENTLY ASKED QUESTIONS
How do you design a comparison study?
FREQUENTLY ASKED QUESTIONS
What should be included in study designs for comparison and reproducibility studies that support a Dual Submission?
FREQUENTLY ASKED QUESTIONS
What content should be included in a Dual Submission?
FREQUENTLY ASKED QUESTIONS
When should a Dual Submission be submitted?
FREQUENTLY ASKED QUESTIONS
What is the difference between a 510(k) and a CLIA Waiver?
FREQUENTLY ASKED QUESTIONS
How should you use animal studies in preparation for a regulatory submission?
FREQUENTLY ASKED QUESTIONS
What are some popular post-mortem imaging and assessment methods?
FREQUENTLY ASKED QUESTIONS
What are some specific recommendations for animal study monitoring?
FREQUENTLY ASKED QUESTIONS
What are some factors to consider in the evaluation of how a device affects an animal?
FREQUENTLY ASKED QUESTIONS
What are the recommendations for food, water, and basic husbandry within animal studies?
FREQUENTLY ASKED QUESTIONS
How should animal allocation to experimental grouping be done in animal studies?
FREQUENTLY ASKED QUESTIONS
How should animal quarantine and conditioning be performed?
FREQUENTLY ASKED QUESTIONS
What should you consider animal identification in an animal study?
FREQUENTLY ASKED QUESTIONS
What should you consider for study equipment in an animal study?
FREQUENTLY ASKED QUESTIONS
What should you consider for research controls in an animal study?
FREQUENTLY ASKED QUESTIONS
What should you consider in designing or choosing the facilities for an animal study?
FREQUENTLY ASKED QUESTIONS
What personnel are key to the success of your animal study?
FREQUENTLY ASKED QUESTIONS
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