Drug tests on Humans or Clinical Studies
Clinical trials, also
known as clinical studies, test potential
treatments in human volunteers to see whether they should be approved for wider
use in the general population. A treatment could be a drug, medical device, or
biologic, such as a vaccine, blood product, or gene therapy. Potential
treatments, however, must be studied in laboratory animals first to determine
potential toxicity before they can be tried in people. Treatments having
acceptable safety profiles and showing the most promise are then moved into
clinical trials.
Although "new"
may imply "better," it is not known whether the potential medical
treatment offers benefit to patients until clinical research on that treatment
is complete. Clinical trials are an integral part of new product discovery and development and are
required by the Food and Drug Administration before a new product can be
brought to the market.
The FDA is committed to
protecting the participants of clinical trials, as well as providing reliable
information to those interested in participating. Recently, unethical behavior
on the part of some researchers has shaken the public trust and prompted the
federal government to establish regulations and guidelines for clinical
research to protect participants from unreasonable risks.
Although efforts are made
to control risks to clinical trial participants, some risk may be unavoidable
because of the uncertainty inherent in clinical research involving new medical
products. It's important, therefore, that people make their decision to
participate in a clinical trial only after they have a full understanding of
the entire process and the risks that may be involved.
Forms & Submission Requirements
Investigational New Drug Forms (IND)
|
·
FDA 1571 (pdf) Investigational New Drug
Application
·
FDA 1572 (pdf) Statement of
Investigator
·
Instructions for completing FDA forms 1571 and
1572
·
FDA Form Distributions Page.
includes links to:
Certification: Financial Interest and Arrangements of Clinical Investigators Disclosure: Financial Interest and Arrangements of Clinical Investigators MedWatch: FDA Medical Product Reporting Program - Voluntary MedWatch: FDA Medical Products Reporting Program - Mandatory
·
For electronic form submissions, see Electronic Regulatory Submissions
and Review.
|
New Drug Application
Forms (NDA)
|
·
Form FDA-356h (pdf) Application to Market a
New Drug, Biologic, or An Antibiotic Drug For Human Use
·
Form FDA-3397 (pdf) User Fee Cover Sheet
·
Form FDA-3331 (pdf) New Drug Application Field
Report
|
Abbreviated
New Drug Application Forms (ANDA) for Generic Drug Products
|
·
Form FDA-356h (pdf) Application to Market a New
Drug, Biologic or An Antibiotic Drug For Human Use
|
Orphan
Drug Products (for rare diseases and disorders)
·
There is no form, but there is a prescribed
format for application for orphan drug status. The section from the regulations
that describes the format can be found on this website on the The Orphan Drug Act and Related Law
and Regulations page.
Electronic Regulatory
Submission and Review (ERSR)
·
Regulations and Instructions for
Submitting Drug Applications Electronically. This webpage provides for
information on CDER's program to enable the electronic submission of regulatory
information to the Center and the review of it by CDER staff.
Guidelines for Waiver Requests
Guidelines for requesting waiver to
current supported clinical study data standard versions. This
webpage provides information on submission of data that does not conform to
currently supported standard versions.Code of Federal Regulations for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics License Applications (BLAs)
The following Code of Federal Regulations(CFR) sections provide regulations for INDs, NDAs and BLAs. All parts of section 21 of the Code of Federal Regulations are also available.
·
CFR
Sections for BLAs
Manual of Policies and Procedures (MaPPs)
MaPPs provide official instructions for internal practices and procedures followed by Center for Drug Evaluation and Research (CDER) staff to help standardize the IND and NDA review process. All CDER MaPPs are available from the MaPP Index web page.
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