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According to FDA , a new drug is any that is not recognised as being safe and effective in the conditions recommended for it use among experts who are qualified by scientific training and experience.
A combination of two or more old drugs or a change in the usual proportions of drugs in an established combinations product is considered new if the change introduces a question of safety or efficacy.
A change in a previously approved drug products formulation or method of manufacture constitutes newness under the law.
NEW DRUG DEVELOPMENT PROCESS
New chemical entity Pre clinical studies Investigational new drug application(IND) Clinical trials New drug application. Post marketing. Surveillance.
INVESTIGATIONAL NEW DRUG APPLICATION(IND)
of rights and safety of the subjects to ensure that the investigational plan is sound and is design to achieve the stated objectives. No delay in use of the drug in human subjects for not less than thirty days from the date of the FDA acknowledges the receipt of application. Delay making the investigation being placed on a clinical hold.
CONTENT OF THE IND
The c te t f the I re lati s a is s equirements:
s r¶s i f r ati . s I esti ati it r i f r ati . Re ie a e al ati i f r ati . tract research r a izati . hase i e tit . I tr ct r state e t a e eral i esti ati la . escri ti f i esti ati al la . Hist r f re i s huma ex erie ce. hemistr , ma ufacture a c tr l i f rmati harmac l a t xic l i f rmati . re i usl i esti ate rug i f rmati c mponent. linical protocol. ommitment. Investigator rochure. ommitment underta ing.
is as s ecifie i the c e f fe eral itte er a c er sheet (f r -1571).
FDA FORM 1561 FOR IND FILING
IND FLOW CHART
PRE IND MEETINGS On request FDA will advice sponsor¶s on scientific technical of formatting concerns elating to the preparation and submission of IND . It includes Advice on adequacy of data to support an investigational plan. Design of clinical trial. Filing of NDA.
NEW DRUG APPLICATION I trod ctio
The new drug application (N D A) is a critical component in the drug approval process. The NDA contains Clinical and no clinical test data and analyses, Drug chemistry information, and Descriptions of manufacturing procedures. An NDA consists of thousands of pages of information to be reviewed by FDA teams composed of highly qualified individuals with e pertise in their respective technical fields.
Most of the FDA guidelines regarding NDAs were written and implemented in early 98 . NDA shares many common elements with the Common Technical Document (CTD) developed by the IC Introduction
ASSEMBLING APPLICATIONS FOR SUBMISSION
Assembling Applications for Submission The FDA requires drug sponsors to submit multiple copies of the NDA . The field copy In 99 the FDA¶s Center for Drug Evaluation and esearch (CDE ) published guidelines that allow sponsors to submit NDAs electronically instead of on paper. THE A CHIVAL COPY. THE EVIEW COPY. THE FIELD COPY.
1: Inde NDA Section 2: Labeling NDA Section 3: Application Summary NDA Section 4: Chemistry, Manufacturing, and Controls (CMC) NDA Section : Nonclinical Pharmacology and To icology NDA Section 6: Human Pharmacokinetics and Bioavailability NDA Section : Microbiology NDA Section 8: Clinical Data NDA Section 9: Safety Update eports NDA CONTENTS 10: Statistics NDA Section 11: Case eport Form Tabulations NDA Section 12: Case eport Forms (C Fs) 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 NDA CONTENTS
NDA FLOW CHART
FDA FORM356(h) FOR NDA FILING
Abbreviated New Drug Application is an application for generic drug approval for an existing licensed medication or approved drug.
³A drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use´
It termed "abbreviated" because they generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
BASIC GENERIC DRUG REQUIREMENTS
The characteristics required to gain FDA approval for a generic drug product. Same active ingredient . Identical properties. Same indications and precautions. Bio-equivalency. Same batch to batch requirements. Manufacture under the same standards of FDA, CGMP.
GOAL OF ANDA
To reduce the price of the drug. To reduce the time development. Increase the bioavailability of the drug in comparison to references list drug
DRUGS APPROVED BY FDA
Dermatology/Plastic Surgery Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010 Zyclara (imiquimod); Graceway; For the treatment of actinic keratoses of the face and scalp, Approved March 2010 Cardiology/Vascular Diseases Pradaxa (dabigatran etexilate mesylate); Boehringer Ingeleheim; For the risk reduction of stroke and embolism due to atrial fibrillation, Approved October 2010 Tekamlo (aliskiren + amlodipine); Novartis; For the treatment of hypertension, Approved August 2010 Nephrology/Urology Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010 Neurology Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010
ANDA FLOW CHART
CONCLUSION Advances in the field Genomic and Bioinformatics will help in the identification of potential drug targets especially related to specific disease targets in the future. Therefore, future is brimming with opportunity and challenge in identifying the critical targets and designing of safe and effective drugs that interact with these targets.
Ansel¶s Pharmaceutical Dosage Forms & Drug Delivery Systems. Industrial Pharmacy By Lachhman Liebermann. www.innovation .org .com www.fda.gov.in www.sciencemag.org www.drugs.com/new-drugapplications www.authorstream.com www.novartis.com/research/drugdiscovery
´If at the end of my career, I can look back and know that something I did made a difference in one Patient somewhere in the world, that I·ll be more satisfying and and gratifying than anything I can possibly imagineµ