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Ò©Ò©ANDA Process

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An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's left for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. ҩ루ANDAϱ FDA ҩƷоķҩ칫ңڷҩ׼Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. һ׼߿۸÷ҩṩȫЧ۵Ʒ

A generic drug product is one that is comparable to an innovator drug product in dosageform, strength, route of administration, quality, performance characteristics and intended use. ҩڼͣ÷ʽ;ǺԭҩͬġAll approved products, both innovator and generic, are listed in FDA's Buy Book at Lowest Price on Amazon

(Orange Book). б׼ҩƷԭҩͷҩ FDA ϡ

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. ҩ뱻Ϊ롱ΪǻϲҪٴǰϣʵ飩ٴϣʵ飩ȷȫԺЧԡInstead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). ҩ߱ҪѧǵIJƷЧģҲ˵ԭҩܱ֣ͬOne way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. ѧ֤ЧԵһַȡ2436 λ־ԸⶨҩѪеʱ䡣This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. ʵҩʣrate of absorptionöȣ˷ҩͿƾԭҩбȽϡThe generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. ҩԭҩͬʱڽͬĻԳɷִ䵽ߵѪ

Using bioequivalence as the basis for approving generic copies of drug products was

established by the ""also known as the Waxman-Hatch Act. ЧΪ׼ҩĻǸ 1984ġȷģ÷Ҳ֮Ϊά˹淨This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. ͨ FDA ׼Ʒҩķư汾жаظԵٴӿϱ˵ķҩĻáAt the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. ͬʱƷҩҲΪҩרֲDzƷͨ FDA ׼ʧʱ䡣Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation. Ʒҩڸı䷽ʱҲҪкͷҩһЧʵ顣For more information on generic drug bioequivalency requirements, please see the chapter entitled "FDA Ensures Equivalence of Generic Drugs" in ""ڷҩЧԷҪĸϢμСFDAȷҩЧԡһ¡

The provides additional information to generic drug developers, including an interactive flowchart presentation of the ANDA review process, focusing on how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing. Ϊҩṩ˸ϢһԵ ANDA ͼصCDERҩƷۺоģ׼ҩǰȷ䰲ȫԺЧԵġGeneric drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.ҩĵЧϣѧϣҪҩƷǩϢȡ

This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a generic drug to market. ַΪҩҵأѧλ˽Ӫ֯֯жԽҩгȤĸ˶ƵġEach of the sections below contains information from CDER to assist you in the ANDA application process. ÿһ½ڶ CDER ϢΪ ANDA ṩClick on a link to go directly to a section.ֱӽӦ½ڡ

Resources for ANDA Submissions

ANDA ݽԴ

The following resources have been gathered to provide you with the legal requirements of an ANDA application, assistance from CDER to help you meet those requirements,and internal ANDA review principles, policies and procedures.ԴһΪṩ ANDA ķҪ CDER ֧԰ǵҪANDA ڲԭߺͳ

Guidance Documents for ANDAs

ANDA ָļ

Guidance documents represent the Agency's current thinking on a particular subject.ָļFDA ijһĵǰThese 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. ЩļּΪFDA Ա/(Sponsor)/׼ȷṩָϣͬʱҲΪܹܲƷơͲԵȷṩָϡThey also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures. ҲƶԴﵽЩڻFDA淽һԣִгBecause guidances are not regulations or laws, they are not enforceable,either through administrative actions or through the courts. ΪָϼȲǷҲǷɣִͨлͨԺûǿԡAn alternative

approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both.а취˷/򷨹Ҫð취ҲǿʹõġFor information on a specific guidance document, please contact the originating office. ijһָָϵϢ뷢칫ϵ

The FDA has numerous guidances that relate to ANDA content and format issues. FDA кܶ ANDA ݺ͸ʽָϡBelow is a list of some recent Guidances

of interest. ΪһЩָϵбSee Drug Information Branch's for a complete list of available guidances online and instructions on how to obtain them. ڿ߻ָϵбλǵָμҩƷϢMost of these documents are in Adobe Acrobat format also know as PDF. Щļ󲿷ֶ Adobe AcrobatʽģҲ֮Ϊ PDF ʽThe free upgrade to Adobe Acrobat 3.0 or higher is recommended,especialy if you have difficulty openingany of the documents below. Ƽʹ Adobe Acrobat 3.0 棬߰汾رǵļʱFor information on a specific guidance document,please contact the originating office.ijָļϢ뷢칫ϵ

Guidance documents to help prepare ANDAs are listed together on CDER's Guidance Document Index webpage in the following categories:

ANDAָļ·༯CDER ָļҳϣ

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& 8226; [url=guidance.htm Generics (Draft)]Generics (Draft-Distributed for comment purposes only)) [url=guidance.htm Generics (Draft)]ҩݰã

Procedural Draft: (Issued 10/1999, Posted 12/7/1999). 199910·У1999127չ棩漰롣This provision permits FDA to rely, for approval of an NDA, on data not developed by the applicant. 涨 FDA ׼NDA ʱϡ

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& 8226; Optional Format:(Issued 10/2000, Posted 10/27/2000). ѡʽ200010·У20001027չ棩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. ָ϶׼ NDA INDinvestigational new drugоеҩ׶νöȺЧо׼Ϊ ANDA Чо׼ΪNDA ANDA ijЩ׼ǰ׶νЧоаġ

& 8226; 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. ҩܵDMFǽ FDA ļ FDA ṩһҩĴ桢װʩջʵȷϸϢ

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& 8226; (Issued 7/12/1993, Posted 11/26/99) Clarifies CDER's decisions to refuse to receive an incomplete application. 1993712շУ1999 1126չ棩CDERܾľ

& 8226; . This database contains all inactive ingredients present in approved drug products or conditionally approved drug products currently marketed for human use. ݿ׼ҩƷ׼ҩƷезǻԳɷݿ⡣

Laws, Regulations, Policies and Procedures ɡ桢ߺͳ

The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. FDA ʹִƶķɺ FDA ķԱߵĽȫͲƲ is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. ʳƷҩƷͻױƷʳƷҩƷɣкܶͬ෨㷺ġThe law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that al labeling and packaging is truthful, informative, and not deceptive.ּȷʳƷǴġɰȫʳõġģȷҩƷҽеԤڵʹ÷ΧǰȫЧģȷױƷǰȫģɿɿԭģȷеıǩͰװǿţʵģҲթԡ

Code of Federal Regulations (CFR)

The final regulations published in the (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. ÿ칫IJݰ鰸ͨȣϹշᱻ¼CFR  The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. 汻ֳ 50 ⣬ЩĹ㷺The FDA's portion of the CFR interprets the and related statutes. 棨CFRFDAֽʳƷҩƷͻױƷصķ档Section 21 of the CFR contains most of the regulations pertaining to food and drugs. 棨CFR21ְ˾󲿷ʳƷҩƷط档 The regulations document most actions of all drug sponsors that are required under Federal law. Щ¼ҪĵҩƷ˵ľ󲿷ֻThe following regulations apply to the ANDA process:Щ ANDA ̣

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& 8226; . For more information on retention samples, please see Bioequivalence Study Retention Samples. ĸϢμЧо

Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule. [TXT] [PDF] (Issued and posted 12/19/2002) öȺЧҪ󣻼룻շ[TXT] [PDF]20021219շй

& 8226; 21CFR Part 310 New Drugs Ò©

MaPPs ߺͳֲ

CDER's Manual of Policies and Procedures (MaPPs) provide official instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities, both internal and external. CDER ߺͳֲ(MaPPs)ΪCDER Աѭڲ淶ͳṩƶ԰ʵҩƷ̺ڲⲿı׼MaPPs define external activities as well. MaPPs. ߺͳֲͬҲⲿAll MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures. ڿԻеߺͳֲᣨMaPPsԸõߡ塢ԱְͳMaPP documents to help prepare ANDAs are listed together on CDER's Manual of Policies and Procedures webpage. ANDA ߺͳֲ

(MaPPs) CDER ߺͳֲᣨMaPPsҳϡ

& 8226; Chapter 5200 - Generic Drugs Ò©

ANDA Forms and Electronic Submissions ANDA ͵

& 8226; ANDA Checklist for Completeness and Acceptability=740) window.open('http://www.fda.gov/cder/graphics/pdf.gif');" src="http://www.fda.gov/cder/graphics/pdf.gif" onload="if(this.width>'740')this.width='740';" border=0> ANDA ԺͿɽԵĺ˶Ա[Wordĵ](Posted 4/19/2006)

& 8226; FDA Form 356h. Application to Market a New Drug for Human Use/Antibiotic Drug for Human Use ҩ/¿ص

& 8226; The CDER Office of Generic Drugs has developed a guidance document entitled

Providing Regulatory Submissions in Electronic Format-ANDAs [PDF version]](Issued 6/2002, Posted 6/27/2002) to assist applicants making regulatory submissions in electronic format of abbreviated new drug applications. CDER ķҩ칫ѾƶһΪԵӸʽύANDA [PDF version]20026·У2002627չ棩԰߽ANDAĵӸʽݽThis guidance should be used in conjunction with the following guidances: ָЩָϽʹã

Guidance for Industry: Providing Regulatory Submissions in Electronic FormatCGeneral Considerations. ҵָϣԵӸʽݽ롪ˡ=740) window.open('http://www.fda.gov/cder/graphics/pdf.gif');" src="http://www.fda.gov/cder/graphics/pdf.gif" onload="if(this.width>'740')this.width='740';" border=0>

Regulatory Submissions in Electronic Format; New Drug Applications. ԵӸʽݽ룺ҩ=740) window.open('http://www.fda.gov/cder/graphics/pdf.gif');" src="http://www.fda.gov/cder/graphics/pdf.gif" onload="if(this.width>'740')this.width='740';" border=0>

& 8226; For more information on electronic submissions, see Electronic Regulatory Submission and Review. ڵӵݽĸϢμӸʽݽ

Related Topics

& 8226; Investigational New Drug Application ҩо루൱ҹġٴо롱 Provides resources to assist drug sponsors with submitting applications for approval to begin new drug experiments on human subjects. ҩƷίߣDrug sponsorṩԴ԰ݽʼҩ׼롣

& 8226; New Drug Application (NDA) ҩ Provides resources to assist drug sponsors with submitting applications for approval to market a new drug. ҩƷίߣDrug sponsorṩԴ԰ݽҩе׼롣

& 8226; Drug Application Regulatory Compliance ҩƷĺϷ The approval process for new drug applications includes a review of the manufacturer's compliance with Current Good Manufacturing Practice. This web page provides resources to help meet compliance. ҩ׼̰GMP Ե

& 8226; Information for Clinical Investigators ٴоԱ֪ Provides regulations and guidelines to scientists who design and run experiments (clinical trials) to test the safety and effectiveness of new drugs on human subjects. Ϊƺͽʵ飨ٴ飩ԼҩİȫԺЧԵĿѧṩָ

& 8226; Small Business Assistance Program Сֳ֧

& 8226; Electronic Regulatory Submission and Review ӵݽ(ERSR) Provides information on electronic drug applications, application reviews, Electronic Document Room, and other ERSR projects. ṩҩƷ롢󡢵ļҺ ERSR ĿϢ

& 8226; Post Drug-Approval Activities ]ҩƷ׼ The goal of CDER's post drug-approval activities is to monitor the ongoing safety of marketed drugs. CDERҩƷ׼ĿǼҩƷİȫԡThis is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk. ͨҩƷк֪ΪҩƷգ˵ӦԸ÷յķʽʵֵġ

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