seminar topic on nda and anda

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SEMINAR ON:

SEMINAR ON NDA (NEW DRUG APPLICATION ) AND ANDA (ABBRIVATED NEW DRUG APPLICATION)

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A drug is said to be new if it is manufactured by different manufacturer or uses different excipients or use for a different purpose NEW DRUG APPLICATION (NDA)

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The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. Goals 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 drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain. Whether the methods used in 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

PRIMER ON FDA’S NDA REVIEW PROCESS :

PRIMER ON FDA’S NDA REVIEW PROCESS Review Clock . The review clock is the time between FDA’s receipt of the application and FDA’s decision. The PDUFA II calls forFDAinFY2002toreviewandactupon90 percent of standard NDAs within 10 months and 90 percent of priority applications within 6 months. Priority applications are for drugs that are a significant improvement over drugs already on the market to treat the same condition. Standard applications are applications not classified as priority . 2. Contents of a New Drug Application . A sponsor, typically a pharmaceutical company, submits the NDA to FDA to obtain marketing approval for a drug within the U.S. The application contains data regarding the safety and efficacy of the drug that the sponsor obtained during its research and development. These data include the results of clinical trials, pharmacology and toxicology data, chemistry and manufacturing data, and proposed packaging and labeling information

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3.Filing Review. When FDA receives an application, the review clock begins. The FDA assigns the application to the appropriate therapeutic review division, of which there are 15. The FDA has 60 days, from the receipt of the application, to determine whether it is adequate for review. If the application is deemed inadequate or incomplete, FDA can refuse to file it and the sponsor can resubmit it later. If the application is complete, FDA notifies the sponsor that the application has been filed. 4.Reviews within Individual Disciplines. After the application is filed, FDA assigns the application to a team of multi-disciplinary reviewers. These reviewers are referred to as primary reviewers. They represent a variety of scientific disciplines, including medicine, pharmacology, statistics, and chemistry.

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5.Advisory Committees. The FDA may convene an advisory committee to assist with the review of an application. The committee comprises scientific experts from outside FDA and may also have consumer, patient, and industry representatives. The committee conducts its own review of the application, usually in a public forum, and advises FDA on scientific issues related to the application. It also votes on the action FDA should take with respect to the drug. The committee’s recommendations are not binding on FDA. 6.Communication with Sponsors. Throughout the process, FDA and the sponsor communicate through in-person meetings, telephone conferences, letters, e-mails, and faxes. Communication allows sponsors and FDA to seek clarification, when necessary. 7.Labeling Negotiations . Toward the end of the review process, FDA and the sponsor negotiate the drug’s final package label. Each element of the label requires FDA approval, including the indications, dosing, directions for use, and safety information. 8.Inspections of Manufacturing and Clinical Sites . The FDA inspects the manufacturing facilities for the drug. It may also inspect a sample of clinical trial locations to verify the accuracy of the data contained within the application.

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9.Decision . Once all the reviews are complete, the division director and/or the office director evaluate the reviews and make FDA’s decision. Five office directors oversee the 15 review divisions. The FDA can take three actions: (1) approval – the drug can be marketed in the U.S., (2) approvable – problems exist with the application that need to be addressed before the drug may be approved, and (3) non-approvable – the application has more significant problems that may require additional research on the drug and may require reformulation of the drug product. The review clock ends once FDA makes its decision and issues a letter to the sponsor. 10.Review Cycles. The first-review cycle begins when FDA receives the application and ends when FDA makes its decision. Multiple review cycles occur when an application receives an approvable or non-approvable decision from FDA, and the sponsor revises the application and resubmits it to FDA, starting another cycle. When the sponsor resubmits the application, the review clock restarts and FDA receives either 2 or 6 months to review the revised application, depending on the information in the resubmission. 11.Total Approval Time. Total approval time is from FDA’s receipt of the original application to the application’s approval. This time can include multiple review cycles and the time spent by the sponsor revising the application between review cycles.

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“An application for a license to market a generic (or a duplicate) version of a drug that has already been granted an approval under a full NDA [i.e., the drug has already met the statutory standards for safety and effectiveness]”. ABBRIVIATED NEW DRUG APPLICATION (ANDA)

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Any pharmaceutical invention for which a patent is granted qualifies for a 20-year marketing exclusivity from the date of filing of the patent application. No other manufacturer or company can market the drug during this period. Once the patent is granted to the innovator, it takes 8-10 years before the drug finally reaches the marketplace. This is because the innovator has to conduct three phases of clinical trials on human subjects to evaluate the safety and efficacy profile of the drug. Clinical trials are expensive and can cost up to $400 million This leaves the innovator with 10-12 years of lead-time to realise his research and development costs plus profits. Hence, research molecules are priced at a premium. However, once the patent expires, the drug is freely marketable.

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5. If more than one ANDAs are filed on a particular drug, the first applicant may be entitled to 180 days of marketing exclusivity according to the provisions of Waxman-Hatch Act. 6. To gain this exclusivity, the applicant must identify a process for manufacturing a generic equivalent that is different from inventors process. 7. Prior to the approval, a generic manufacturer has to prove the FDA that his product is equivalent to the branded product. Hence, the manufacturer has to conduct bioavailability and/or bioequivalence studies for his version. 8. Bioavailability studies assess the rate and extent of absorption and levels of concentration of a drug in the blood stream needed to produce a desired therapeutic effect. Bioequivalence studies establish the rate of absorption and the levels of concentration of a generic product

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Brand Name Drug NDA req Generic Drug ANDA req. Chemistry manufacturing . Chemistry manufacturing Controls labeling Controls labeling Testing Animal studies Testing bioequivalence Clinical studies bioavailability Comparison between NDA & ANDA

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Resources for ANDA Submissions The following resources have been gathered to provide the legal requirements of an ANDA application, assistance from CDER to meet those requirements, and internal ANDA review principles, policies and procedures. Guidance Documents for ANDAs Guidance documents represent the Agency's current thinking on a particular subject. 1. 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. 2. They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures. Because guidance's are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. 3. An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both

CONCLUSION:

CONCLUSION At last we can say that generic drus are 1.Safe and effective 2.Affordable 3.Easily available Use with confidence, because generics drugs are of Same quality (must meet the same FDA standards for quality)Same safety ,Same strength ,Approved by the FDA as brand product.

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