We are providing our readers around the world very important piece of information in these articles.
Every pharmaceutical company in world is looking at having its pharmaceutical business spread in western countries like USA or EUROPE.
We are happy to provide articles about pharmaceutical regulatory affairs with respect to US FDA , we are focused to provide detailed information on following topics
1.What is an ( pharmaceutical ) Investigational New Drug Application (IND) Provides resources to assist drug sponsors with submitting applications for approval to begin new drug experiments on human subjects.
2.How to do (Pharmaceutical ) drug Applications submission to us fda for Over-the-Counter Drugs
3.What is ( pharmaceuticals ) Abbreviated New Drug Application (ANDA) Provides resources to assist drug sponsors with submitting applications to market a generic drug or pharmaceutical.
Read where ever it is written as “we” as US FDA and “agency” as or means US FDA and its Regulatory agencies.
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New Drug Application (NDA)
Introduction
For decades, the regulation and control of (pharmaceutical ) new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. 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 ( pharmaceutical ) investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
Whether the ( pharmaceutical ) drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
Whether the ( Pharmaceutical ) drug’s proposed labeling (package insert) is appropriate, and what it should contain.
Whether the methods used in (pharmaceutical ) manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.
The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The following resources provide summaries on NDA content, format, and classification, plus the NDA review process:
Resources for NDA Submissions Are available over US FDA’S website for pharmaceuticals regulatory
Guidance Documents for NDAs Are available over US FDA’S website for pharmaceuticals regulatory
Guidance documents represent the Agency’s current thinking on a particular subject. 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. They also establish policies intended to achieve consistency in the Agency’s regulatory approach and establish inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.
For the complete list of CDER guidances, please see the Guidance Index. For information on a specific guidance document, please contact the originating office.
Guidance documents to help prepare NDAs include: (Are available over US FDA’S website for pharmaceuticals regulatory)
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations (Issued 10/2000, Posted 10/27/2000). This guidance should be useful for applicants planning to conduct bioavailability (BA) and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs.
Changes to an Approved NDA or ANDA [HTML] or [PDF] (Issued 11/1999, Posted 11/19/1999)
Changes to an Approved NDA or ANDA: Questions and Answers [HTML] or [PDF] (Issued 1/2001, Posted 1/22/2001)
Container Closure Systems for Packaging Human Drugs and Biologics. (Issued 5/1999, Posted 7/6/1999)
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application. (Withdrawn as per FR notice, 6/1/2006)
Format and Content of the Microbiology Section of an Application.
Format and Content of the Clinical and Statistical Sections of an Application. (Issued 7/1988, Posted 5/21/1997)
Format and Content of the Summary for New Drug and Antibiotic Applications. (Issued 2/1987, Posted 3/2/1998)
Formatting, Assembling and Submitting New Drug and Antibiotic Applications. (Issued 2/1987, Posted 3/2/1998)
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances.
Submitting Documentation for the Stability of Human Drugs and Biologics. (Issued 2/1987, Posted 3/2/1998)
Submitting Samples and Analytical Data for Methods Validation.
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products.
NDAs: Impurities in Drug Substances (Issued 2/2000, Posted 2/24/2000)
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application. (Issued 2/1987, Posted 3/2/1998)
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application. (Posted 3/2/1998)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. Describes the quantity of evidence, and the documentation of the quality of evidence necessary to support a claim of drug effectiveness.
Drug Master Files. A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Required Specifications for FDA’s IND, NDA, and ANDA Drug Master File Binders
Qualifying for Pediatric Exclusivity. Certain applications may be able to obtain an additional six months of patent exclusivity.
PET Drug Applications – Content and Format for NDAs and ANDAs [HTML] or [PDF] (Issued 3/7/2000, Posted 3/7/2000)
These documents are available over US FDA’S website for pharmaceuticals regulatory
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