NDA – Flashcards

FDCA of 1938--NDA needed for safety. Created in response to sulfanilamide tragedy. Kefauver-Harris Amendment of 1962--NDA is needed for safety and efficacy. Created in response to thalidomide.

-application for sales and marketing of a drug in the US -includes information from non-clinical studies; clinical trials on safety and efficacy; chemistry, manufacturing and controls (CMC); labeling; risk vs benefit

1. Traditional NDA 2. 505(b)(2) NDA 3. Abbreviated NDA

-new molecule entity -new salt of previously approved drug -new formulation of previously approved drug -new combination of two or more drugs -already marketed drug product - duplication (i.e. new manufacturer) -new indication -already marketed drug product (no previously approved NDA)

1. Propriety name submission and review: submit no later when the NDA is submitted. FDA reviews safety and promotional aspects of proposed name (i.e. implies superiority? attempts to minimize risk? LASA?) 2. Establish registration and NDC number: must register facility prior to approval 3. Pre-NDA meeting with FDA: not required but highly recommended; 4-6 months prior to anticipated submission date; purpose is to ensure all the necessary information required by the agency is being submitted in order for a decision to be made.

1. application form (form 356h) 2. cover letter 3. user fee 4. patent exclusivity 5. summary (safety, efficacy, ClinPharm) 6. Meeting minutes with FDA 7. Clinical study reports 8. CMC 9. Labeling 10. literature references

Module 2-5

-regional admin info -varies by countries -top of pyramid -includes forms, cover letters, administrative info, meetings, labeling, promotional material, and proprietary names

-includes summaries -quality overall summary -nonclinical overview -clinical overview -nonclinical summary -clinical summary

-focus is on quality measures -chemistry, manufacturing, and controls (CMC) -drug substane (DS) -drug product (DP) -includes stability data

-non-clinical study reports -includes nonclinical pharmacology and toxicology -PK data -carinogenicity -developmental and reproductive toxicology

-clinical data -clinical study reports -full reports of studies pertinent to PK using human biomaterial -reports of human pharmacodynamic studies -reports of efficacy and safety studies -reports of postmarketing experience -literature reference

-created by Congress in 1992 -determines the review period for the application -priority = 8 months (6 months for supplemental NDA) -standard = 12 months (10 months for supplemental) -sped up the review process as at the time approval took on average of 2.5 years

-ODEI -ODEII -ODE III -ODE IV: division of nonprescription drug produts; medical imaging; and pediatric and maternal health

-Preapproval inspections -Primary review: --clinical reviewer --pharmacology/toxicology reviewer --chemistry reviewer --statistical reviewer --biopharmaeutics reviewer --microbiology reviewer

-convene to discuss questions the FDA has about a drug application -composed of experts in specific therapeutic area or topic at hand -make recommendations/vot on key issues (recommendations are NOT binding) -many are open to the public

1. an approval letter or 2. a complete response letter

-FDA modernization act of 1997 --Title 1, Section 130: sponsors agree to report FDA annually progress of post marketing commitments (PMC)

-FDA can require sponsors to conduct studies and clinical trials (Post marketing requirements) -FDA can require sponsors to make safety-related label changes -FDA can require sponsors to develop/comply with REMS

-risk evaluation and mitigation strategies -required by FDA to weigh benefit vs risk: prior to approval or post-approval -healthcare professionals need to follow safety procedures prior to prescribing, shipping, or dispensing the drug