NDA & ANDA

Views:
 
Category: Entertainment
     
 

Presentation Description

No description available.

Comments

By: jebypc (114 month(s) ago)

nice presentation. can you please mail me this ppt at [email protected]

Presentation Transcript

PowerPoint Presentation:

NEW DRUG APPLICATION & ABBREVIATED NEW DRUG APPLICATION NEW DRUG APPLICATION & ABBREVIATED NEW DRUG APPLICATION PRESENTED BY SOWMYA K BALAN 12/22/2011 1

FDA s DEFINITION OF NEW DRUG:

FDA s DEFINITION OF NEW DRUG A new drug is any that is not recognized as being safe and effective in the conditions recommended for its use among experts who are qualified by scientific training and experience 12/22/2011 2

PowerPoint Presentation:

12/22/2011 3

PowerPoint Presentation:

12/22/2011 4

NEW DRUG APPLICATION:

NEW DRUG APPLICATION NDA is a regulatory mechanism that is designed to give FDA sufficient information to make a meaningful evaluation of a new drug The new drug application (N D A) is a critical component in the drug approval process. 12/22/2011 5

PowerPoint Presentation:

New Drug Application since 1938 History 1938 - only required to contain information pertaining to the investigational drug’s safety . 1962 – the Kafauver -Harris Amendments to the FD&C Act. Required to contain evidence that a new drug was effective for its intended use , and established benefits of the drug outweighed its know risks. 1985 – comprehensive revision . 12/22/2011 6

PowerPoint Presentation:

STEPS INVOLVED IN NEW DRUG APPLICATION (NDA) Submission FDA Review Pre-approval Plant inspection FDA action 12/22/2011 7

PowerPoint Presentation:

12/22/2011 8

All NDA must contain following information:

All NDA must contain following information Preclinical laboratory and animal data Human pharmacokinetic and bioavailability data Clinical data Method of manufacturing,processing and packaging A description of new drug A list of relavant patents for the drug Its manufacture or claims and proposed labelling 12/22/2011 9

PowerPoint Presentation:

Description Proprietary and established name of drug ; dosage form; ingredients; chemical name; and structural formula. Clinical Pharmacology Summary of the actions of the drug in humans; in vitro and in vivo actions in animals if pertinent to human therapeutics; pharmacokinetics Indication and Usage Description of use of drug in the treatment, prevention, or diagnosis of recognized disease or condition 12/22/2011 10

PowerPoint Presentation:

Contra-Indications Description of situations in which the drug should not be used because the risk of use clearly outweighs any possible benefit Warnings Description of serious adverse reactions and potential safety hazards, subsequent limitation in use, and steps that should be taken if they occur. Precautions Information regarding any special care to be exercised for the safe and effective use of the drug . 12/22/2011 11

PowerPoint Presentation:

Adverse Reactions Description of undesirable effect(s) reasonably associated with the proper use of the drug Drug Abuse/Dependence Description of types of abuse that can occur with the drug and the adverse reactions pertinent to them Overdosage Description of the signs, symptoms, and laboratory findings of acute overdosage and the general principles of treatment. - 12/22/2011 12

PowerPoint Presentation:

Dosage/Administration Recommendation for usage dose , usual dosage range, and if appropriate, upper limit beyond which safety and effectiveness have not been established How Supplied Information on the available dosage forms to which the labeling applies 12/22/2011 13

PowerPoint Presentation:

NDA CONTENT AND FORMAT REQUIREMENTS NDA must provide all relevant data and information collected during the product’s research and development. Guidelines related to NDA content and format issues  from CDER’s Drug Information Branch (DIB) : http://www.fda.gov/cder/guidance/index.htm 12/22/2011 14

NDA SUBMISSION:

NDA SUBMISSION Contains a complete presentation of all pre clinical and clinical results that the sponsor has obtained during investigation of new drug. The applicant submits 3 copies of NDA Archival copy Review copy Field copy 12/22/2011 15

PowerPoint Presentation:

The Archival Copy : It must contain four copies of the Labeling section. It must contain three additional copies of the CMC and Methods Validation Package in a separate binder. The archival copy is the only copy that contains the Case Report Tabulation and Case Report Forms 12/22/2011 16

PowerPoint Presentation:

The Review Copy : Intended for reviewers in the corresponding technical disciplines. I n addition to the appropriate technical section, each review copy also includes The cover letter, Form FDA-356h, The administrative sections, Comprehensive NDA index Individual table of contents, The Labeling section, and The Application Summary . 12/22/2011 17

PowerPoint Presentation:

The Field Copy : T he Field Copy Required since 1993 for use by FDA inspectors during pre approval facilities inspections It includes Cover letter and Form FDA-356h, The administrative sections, The comprehensive NDA index Individual table of contents, The Labeling section, The Application Summary and CMC, and Methods Validation 12/22/2011 18

PowerPoint Presentation:

NDA CONTENTS : The NDA may have as many as 20 different sections in addition to the Form FDA-356h itself. The specific contents of the NDA will depend on T he Nature of the drug The information available at the time of submission 12/22/2011 19

PowerPoint Presentation:

NDA Section 1: Index NDA Section 2: Labeling NDA Section 3: Application Summary NDA Section 4: Chemistry, Manufacturing, and Controls (CMC) NDA Section 5: Nonclinical Pharmacology and Toxicology NDA Section 6: Human Pharmacokinetics and Bioavailability NDA Section 7: Microbiology NDA Section 8: Clinical Data NDA Section 9: Safety Update Reports 12/22/2011 20

PowerPoint Presentation:

NDA Section 10: Statistics NDA Section 11: Case Report Form Tabulations NDA Section 12: Case Report Forms (CRFs) NDA Section 13: Patent Information NDA Section 14: Patent Certification NDA Section 15: Establishment Description NDA Section 16: Debarment certificate NDA Section 17: Field copy certification NDA Section 18: User fee coversheet NDA Section 19: Financial Disclosure NDA Section 20: Other/ Pediatrics 12/22/2011 21

NDA REVIEW PROCESS:

NDA REVIEW PROCESS Reviewed by FDA 180 day period – REVIEW CLOCK 12/22/2011 22

PowerPoint Presentation:

Usually, six different teams are responsible for reviewing an NDA. The teams are organized by technical reviewing responsibilities: Clinical Pharmacology T oxicology Chemistry Statistics Biopharmaceutical Microbiology . 12/22/2011 23

PowerPoint Presentation:

REVIEW PROCESS Medical Review Exclusively physicians. Medical reviewers are responsible for evaluating the clinical sections of submissions Lead role in the IND or NDA review, Responsible for synthesizing the results of the animal toxicology, human pharmacology and clinical review to formulate the overall basis for a recommended Agency action on the application. 12/22/2011 24

PowerPoint Presentation:

Biopharmaceutical Review Pharmacokineticists evaluate the rate and extend to which the drug ’ s active ingredient is made available to the body and the way of distribution and elimination from the human body. Statistical Review Statisticians evaluate the statistical relevance of the data in the NDA Purpose- give the medical officers a better idea of the power of the findings to be extrapolated to the larger patient population in the country. 12/22/2011 25

PowerPoint Presentation:

Microbiology Review only for anti-infective drugs . -the biochemical basis of the drug’s action on microbial physiology; -the drug’s antimicrobial spectra, including results of in vitro preclinical studies -any known mechanisms of resistance to the drug -clinical microbiology laboratory methods needed to evaluate the effective use of the drug. 12/22/2011 26

PowerPoint Presentation:

Advisory Committees To obtain outside advice and opinions from experts advisors –benefit of wider national expert input to final agency decisions. Committee recommendations are not binding on CDER, but carefully considered when deciding drug issues. . 12/22/2011 27

PowerPoint Presentation:

Reviews complete and Acceptable? Purpose of primary review process- Confirm and validate the sponsor’s conclusion that a drug is safe . Reanalysis or an extension of the analyses performed by the sponsor and presented in the NDA. Extensive communication b/w review team members Completed technical reviews  written evaluation of the NDA that presents conclusions and recommendations on the application.  action letter 12/22/2011 28

PowerPoint Presentation:

Three possible action letter at the conclusion of CDER’s review of an application Not Approvable Letter : List the deficiencies in the application and explanation of disapproval. Approvable Letter : Signals that, ultimately, the drug can be approved. Lists minor deficiencies that can be corrected. (i.e., labeling changes). Approval Letter : States that the drug is approved. May follow an approvable letter, but can also be issued directly. 12/22/2011 29

PowerPoint Presentation:

NDA REVIEW PROCESS Applicant (Drug Sponsor) NDA Medical Biopharmaceutical Pharmacology Statistical Chemistry Microbiology Application File able? Refuse to File-Letter Issued Advisory Committee Meeting Meetings with Sponsor Additional Info or Revisions Requested or Submitted Reviews Complete and Acceptable? Sponsor Review Labeling Review Acceptable? Inspection Of Sites Acceptable? NDA Action Pending Satisfactory Results No No Yes Review by CEDR No Yes Yes Yes 12/22/2011 30

ABBREVIATED NEW DRUG APPLICATION:

ABBREVIATED NEW DRUG APPLICATION The generic pharmaceutical company seeking to market an equivalent to an innovators product uses a significantly less costly, ANDA process They relies on safety and efficacy data supplied by the innovator and only prove to the FDA that their product is equivalent to the branded product 12/22/2011 31

PowerPoint Presentation:

ANDA process eliminates lengthy and costly clinical research phase of development By this method product development takes approximately 3 yrs cGMP has to be followed in all phase of manufacturing process 12/22/2011 32

PowerPoint Presentation:

12/22/2011 33 EVALUATE PATENTS AND DETERMINE STATUS DEMONSTRATE BIOEQUIVALENCE PREPARE ANDA FILE ANDA ANDA REVIEW AND APPROVAL GENERIC PRODUCT LAUNCH

ANDA SUBMISSION & APPROVAL PROCESS:

ANDA SUBMISSION & APPROVAL PROCESS Product selection Physical & pharmacokinetic characterisation Product development Final Approval Pre approval inspection Test batch manufacture Biostudy ANDA submission FDA comment & review period 12/22/2011 34

PowerPoint Presentation:

12/22/2011 35

authorStream Live Help