Pathway for Marketing Authorization Approval of Drug Product in US
Balamuralidhara
V*, Abhishek BV, Nagendra SR
Department of Pharmaceutics, JSS College of Pharmacy, JSS University, India
Citation: Balamuralidhara V, Abhishek BV, Nagendra SR (2017) Pathway for Marketing Authorization Approval of Drug Product in US. J Pharmacovigil Pharm Ther: JPPT-117. DOI: 10.29011/JPPT-117. 100117
1.
Abstract
1.
Introduction
Steps in the Product development life cycle
Step 1: Classify the healthcare product
Step 2: Identify the healthcare claim and/or product label
Step 3: Step
3: Determine the healthcare market
Step 4: Develop
the regulatory strategy
Step 5: Establish
the product development plan
Step 6: Execute
the product development plan
Step 7: Execute
the clinical plan
Step 7a: Prepare
for a pre-submission meeting to support the CTA
Step 8: Collect
the data for regulatory submission
Step 8a: Prepare
for a pre-submission meeting to support licensing application
Step 9: Collate
the data for regulatory submission
Step 10: Ensure post-marketing surveillance
Advantages of Navigation Pathway
Ø
Providing an applicant / regulatory expert on the
website with the most descriptive path to application / regulatory information
is one of the easiest ways to ensure they don't get confused while preparing a
regulatory application / dossier.
Ø
If websites are to attract
application/application services, they need easy browsing experience, and then
the path of navigation of the website will be the main factor in the website
design and development process.
Ø The navigation pathway not only benefits the applicant but also benefits the agency stakeholders, i.e. industry and agency.
2.
Discussion
2.1 United States of America Factsheets
Introduction
The IND is the means through which the sponsor technically obtains this exemption from the FDA. The sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development.
Resources for Ind Submissions
The following resources include the legal requirements of an IND application, assistance from CDER to help you meet those requirements, and internal IND review principles, policies and procedures.
Guidance Documents for IND
These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.
Laws, Regulations, Policies and Procedures
The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labelling and packaging is truthful, informative, and not deceptive.
Code
of Federal Regulations (CFR)
The FDA's portion of the CFR interprets
The Federal Food, Drug, and Cosmetic Act and
related statutes. The CFR is
divided into 50 titles that represent broad areas subject to Federal
regulations. The following regulations apply to the IND application process:
CDER's Manual of Policies and Procedures (Ma PPs)
These documents are
approved instructions for internal practices and procedures followed by CDER
staff to help standardize the new drug review process and other activities
Introduction
The NDA application is the vehicle through which drug
sponsors formally propose that the FDA approve a new pharmaceutical for sale
and marketing in the U.S.
The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
Resources for Ind Submissions
The following resources are provided in the website for understand the legal requirements of a new drug application, assistance from CDER to meet those requirements, and internal NDA review principles, policies and procedures.
Guidance Documents for NDAs:
These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.
Laws, Regulations, Policies and Procedures:
The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labelling and packaging is truthful, informative, and not deceptive.
CDER's Manual of Policies and Procedures (MaPPs):
These documents are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.
Prescription Drug User Fee Act (PDUFA):
This legislation includes authorization for FDA to continue to collect three types of user fees from applicants who submit certain new drug applications.
NDA Forms and Electronic Submissions:
This section provides information on various application forms required for submission of NDA application.
Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the Agency. CDER requests advice from advisory committees on a variety of matters, including various aspects of clinical investigations and applications for marketing approval of drug products.
Guidance
Documents-NDA
Introduction
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Centre for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act
Resources For And a Submissions
The following resources have been gathered to
provide you with the legal requirements of an ANDA application, assistance from
CDER to help you meet those requirements, and internal ANDA review principles,
policies and procedures.
Guidance Documents for ANDAs:
These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.
Laws, Regulations, Policies and Procedures:
The Federal Food, Drug, And Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labelling and packaging is truthful, informative, and not deceptive.
CDER's Manual of Policies and Procedures (MaPPs):
These documents are approved instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities.
ANDA Forms and Electronic Submissions:
This section provides
information on various application forms required for submission of ANDA
application
Figure-1
Figure-2
Figure-3
Figure-4
Figure-5
Figure-6
Figure-7
Chemicals: IND-US |
|
Regulatory Factsheet |
|
Product |
Drugs |
Country |
USA |
Type of Application |
IND |
Life Cycle Phase |
R&D |
Regulatory Department |
Department of Health and Human Services |
Regulatory Agency |
US Food and Drug Administration(FDA) |
Division |
Center for Drug Evaluation & Research (CDER) |
Regulatory Classification |
Chemicals |
Table-1
Sl No. |
CFR Part |
Type of Application |
1 |
21CFR Part 312 |
|
2 |
21CFR Part 314 |
INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval) |
3 |
21CFR Part 58 |
Good Lab Practice for Nonclinical Laboratory [Animal] Studies |
Table-2
Guidance Documents - Ind |
||
Sl No |
Title |
Issued Date |
1 |
Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies |
12/19/12 |
2 |
Current Good Manufacturing Practice for Phase 1 Investigational Drugs |
07/14/08 |
3 |
Exploratory IND Studies |
01/12/06 |
4 |
10/01/00 |
|
5 |
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations |
03/17/14 |
6 |
01/15/04 |
|
7 |
09/01/89 |
|
8 |
|
|
9 |
Immunotoxicological Evaluation of Investigational New Drugs |
10/01/02 |
10 |
11/01/95 |
|
11 |
Safety Assessment for IND Safety Reporting Guidance for Industry |
12/16/15 |
Table-3
Checklist |
Reference Link |
Table-4
Chemicals: NDA-US |
|
Regulatory Factsheet |
|
Product |
Drugs |
Country |
USA |
Type of Application |
NDA |
Lifecycle Phase |
R&D |
Regulatory Department |
Department of Health and Human Services |
Regulatory Agency |
US Food & Drugs Administration (FDA) |
Division |
Center for Drug Evaluation & Research (CDER) |
Regulatory Classification |
Drugs |
Table-5
Sl No |
Title |
Issued Date |
01 |
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations |
03/17/14 |
02 |
Changes to an Approved NDA or ANDA |
04/01/04 |
03 |
Changes to an Approved NDA or ANDA: Questions and Answers |
01/01/01 |
04 |
Container Closure Systems for Packaging Human Drugs and Biologics |
05/01/99 |
05 |
Format and Content of the Microbiology Section of an Application |
01/01/90 |
06 |
Format and Content of the Clinical and Statistical Sections of an Application |
07/01/88 |
07 |
Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications |
02/01/87 |
08 |
Formatting, Assembling and Submitting New Drug and Antibiotic Applications |
02/01/87 |
09 |
Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products |
|
10 |
NDAs: Impurities in Drug Substances |
02/01/87 |
11 |
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application |
02/01/87 |
12 |
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application |
02/01/87 |
13 |
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products |
|
14 |
Drug Master Files: Guidelines |
09/01/89 |
15 |
FDA IND, NDA, ANDA, or Drug Master File Binders |
|
16 |
PET Drug Applications - Content and Format for NDAs and ANDAs_2011 |
08/31/11 |
Table-6
Check List |
Table-7
Reference Link Quality Accreditation |
|
Type of Certificate |
URL website |
GMP |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=211 |
GLP |
http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1 |
GCP |
|
Reference Link |
|
Table-8
Chemicals: ANDA-US |
|
Regulatory Factsheet |
|
Product |
Drugs |
Country |
USA |
Type of Application |
ANDA |
Lifecycle Phase |
MAA |
Regulatory Department |
Department of Health and Human Services |
Regulatory Agency |
US Food & Drugs Administration (FDA) |
Division |
Center for Drug Evaluation & Research (CDER) |
Regulatory Classification |
Chemicals |
Table-9
Table-10
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