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The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs in the United States. An ANDA is a request to the FDA to manufacture and market a generic drug without needing to conduct clinical trials. If approved, the generic drug will be listed in the Orange Book. The ANDA process aims to reduce drug prices and development time compared to innovator drugs. It requires generics to have the same active ingredients and be bioequivalent but not necessarily identical. The Hatch-Waxman Act of 1984 established provisions for ANDA submissions and patent certifications.
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Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
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INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (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.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
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DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
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The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
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• A Transmittal letter
• Administrative information about the submission
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• Typewritten name and title of the signer.
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• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
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sr and cr formulations
This document provides an introduction to sustained release and controlled release drug formulations. It defines sustained release as slowly releasing a drug over 8-12 hours, while controlled release delivers a drug at a predetermined rate for a specified time period. Some key advantages of these formulations are improved patient compliance, better drug utilization, and decreased side effects. Physicochemical drug properties like solubility, permeability and stability can impact whether a drug is suitable for these delivery systems. The document discusses various approaches for sustained and controlled release based on these physicochemical factors.
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The document discusses the process for submitting an Investigational New Drug (IND) application to regulatory agencies like the FDA in the US and DCGI in India to obtain approval to test new drugs in human clinical trials. It explains that an IND application includes preclinical data from animal and lab studies to show safety for testing in humans. It also outlines the types of IND applications and details on protocols, manufacturing, and other information required to be submitted. The application process and timeline for review within 30 days by the FDA is also summarized.
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3) Potential issues with the Hatch-Waxman Act around "evergreening" patents and deals between brand and generic companies that delay generic competition.
Swapnil2
The document provides an overview of the global pharmaceutical industry and the generic drug market. It discusses how the generic drug market is growing faster than the overall pharmaceutical industry. It also summarizes the key requirements for FDA approval of generic drugs, including bioequivalence to the branded version. Additionally, it outlines the Hatch-Waxman Act which aims to balance generic and branded drug competition in the US market.
ANDA FDA APPLICATION
The document discusses the process of drug development and approval, including the role of generic drugs. It covers the following key points:
1. There are 5 stages of drug development from discovery to post-marketing trials. Generic drugs can enter after patents and exclusivity expire through an abbreviated approval process requiring only proof of bioequivalence rather than full clinical trials.
2. The Hatch-Waxman Act of 1984 aimed to balance incentives for innovation with increased generic competition. It established provisions for patent term extensions and periods of marketing exclusivity for innovators as well as an abbreviated approval pathway for generics.
3. Generics must file an ANDA demonstrating bioequivalence to the reference drug and can
NDA and ANDA regulatory approval process
This document discusses the regulatory approval processes for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in the United States. It explains that an NDA contains extensive clinical and non-clinical data submitted by an innovator company to obtain approval for a new drug. An ANDA contains similar data to demonstrate equivalence to an already approved drug for generic versions after patents have expired. The document provides details on the requirements, review processes, and certification pathways for both NDAs and ANDAs.
Abbreviated New Drug Application [ANDA]
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
NDA Vs ANDA
This document provides an overview of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). NDAs are required for new drugs and include extensive clinical trial data to prove safety and efficacy. The review process takes 12-15 years and is more expensive. ANDAs are for generic drugs and do not require new clinical trials, only proof of bioequivalence. The review process takes 1-2 years and is less expensive. Both application types provide information on chemistry, manufacturing, labeling, and clinical data in a standardized format.
ANDA.pptx
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file an application to obtain approval for a generic version of an approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the reference listed drug. If approved, the generic drug can provide a safe, effective, and lower-cost alternative to patients. The ANDA process helps expedite approval of generic drugs and increase competition in the pharmaceutical market.
Naresh... anda ppt
This document provides information about abbreviated new drug applications (ANDAs) and the generic drug approval process. It defines a generic drug and ANDA, outlines the basic requirements for an ANDA, and describes the evolution and key aspects of the ANDA pathway established by the Waxman-Hatch Act of 1984. This includes the requirements for bioequivalence testing and patent certifications that allow generic drugs to be approved without duplicative clinical trials. The Center for Drug Evaluation and Research (CDER) at the FDA is responsible for reviewing ANDAs to approve safe and effective generic drug products.
Generic drugs product development
This document provides a summary of a presentation on generic drugs. It discusses the definition of generic drugs, the generic drug development and approval process, provisions of the Hatch-Waxman Act, and relevant sections of the Code of Federal Regulations. The summary highlights that a generic drug must be equivalent to the branded version in ingredients, dosage, safety and efficacy. It also outlines the steps in generic drug approval via an Abbreviated New Drug Application, including requirements for bioequivalence testing and patent certifications. Additionally, it notes provisions established by the Hatch-Waxman Act related to patent term extensions and patent challenges involved in the generic approval pathway.
ANDA Filling Process
The document discusses generic drugs and the Abbreviated New Drug Application (ANDA) process. It explains that an ANDA contains data to review and approve a generic drug as a safe and effective alternative to the original brand name drug. It provides details on the Hatch-Waxman Act which established the modern generic drug approval pathway and allows generics to reference clinical data from the branded version. The document also outlines the requirements for generic drugs to be approved as well as the various certification pathways in the ANDA process.
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
Global Submission ANDA.pptx
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
To reduce the price of the drug. To reduce the time development. Increase the bioavailability of the drug in comparison to reference list drug.
Global Submission ANDA-.pdf
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Global Submission ANDA.pptx
An ‘Abbreviated New Drug Application (ANDA)’ is an application for a U.S. generic drug approval from FDA under section 505(j) for an existing licensed medication or approved drug. A generic drug product is one that is comparable to a patented drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
Hatch-Waxman Act Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) , also known as the Hatch-Waxman Act.
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, established the modern system of government generic drug regulation in the United States under section 505(j) of the FD&C Act.
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.
GDUFA10 was signed into law to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry.
Office of generic drug (OGD) strongly encourages submission of bioequivalence, chemistry and labeling portions of the application in electronic format.
This guidance details the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications2 and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission.
Generic drug ppt
The document discusses the generic drug development process and the Hatch-Waxman Act. It defines generic drugs as being identical to brand name drugs in active ingredients, dosage form, quality and therapeutic effects. The generic drug approval process involves submitting an Abbreviated New Drug Application to the FDA that demonstrates bioequivalence to the brand name drug. The Hatch-Waxman Act established the modern system of generic drug regulation, providing incentives for generic drugs to gain FDA approval and compensating brand name drugs for patent time lost during regulatory review.
Anda
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
Abbrevated New Drug Applications- Basics
The document discusses Abbreviated New Drug Applications (ANDAs), which are applications for generic drug approval submitted to the FDA. Key points:
- ANDAs are used to gain approval for generic versions of off-patent drugs without requiring costly preclinical and clinical testing, as long as they are proven to be bioequivalent to the branded version.
- The Hatch-Waxman Act of 1984 established the modern ANDA pathway, allowing generics to reference pioneer drug data and challenging patents to bring cheaper drugs to market sooner.
- ANDAs must demonstrate the generic drug is identical to the branded reference drug in active ingredients, strength, dosage form, route of administration, quality and labeling. Bioequival
Similar to Anda.ppt (20)
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
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Journal club 2019 end sem
This document summarizes a study that developed and evaluated N-Acetylcysteine loaded nanostructure lipid carriers (NLCs) to treat ischemic stroke. The study prepared sesamol-loaded NLCs (S-NLCs) using a high-pressure homogenization method. Characterization of the S-NLCs found them to have a particle size of 200 nm. In vitro tests on PC12 cells showed the S-NLCs protected against oxygen-glucose deprivation-induced cell death. In vivo tests in a rat model of ischemic stroke found treatment with S-NLCs reduced infarct volume and improved spatial memory compared to sesamol solution alone. The S-NLCs
Clinical adna regulatoty approval process
The abbreviated new drug application (ANDA) regulatory approval process allows generic drug manufacturers to obtain approval for generic drug products through the FDA's Office of Generic Drugs. The ANDA review process is similar to the new drug application process but is generally abbreviated because generic drugs do not require clinical trials to establish safety and efficacy since this was already done for the reference listed drug. A key part of ANDA approval is demonstrating bioequivalence to the reference listed drug through bioequivalence studies. Upon approval, generic drugs provide safe, effective, and low-cost alternatives to brand name drugs.
Method of preparation of niosomal in situ gel
Niosomes will be prepared using the thin film hydration method with span 60, Tween 60 as surfactants and cholesterol dissolved in chloroform and methanol. The solvent will be evaporated to form a thin film, which will then be rehydrated with a drug-loaded PBS solution and sonicated. The niosomes will then be incorporated into an in situ gel containing 1% w/w of Carbopol 934 or 940. The niosomal formulation will be characterized by determining entrapment efficiency, particle size using zetasizer, polydispersity index between 0.1-0.4, and zeta potential to confirm stability.
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Anda.ppt
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs in the United States. An ANDA is a request to the FDA to manufacture and market a generic drug, and is abbreviated since it does not require clinical trials like a New Drug Application. The key points covered include basic generic drug requirements, the objective of reducing drug costs, comparisons between innovator and generic drugs and between NDAs and ANDAs, the Hatch-Waxman Act of 1984 which established the ANDA pathway, patent certification requirements, and an overview of the ANDA review process.
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Aquasome presentation
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1.Direct Titration
2.Back Titration
3.Replacement Titration
4.Indirect Titration
Masking agent, Demasking agents
formation of complex
comparition between masking and demasking agents,
Indicators/Metal ion indicators/ Metallochromic indicators/pM indicators,
Visual Technique,PM indicators (metallochromic), Indicators of pH, Redox Indicators
Instrumental Techniques-Photometry
Potentiometry
Miscellaneous methods.
Complex titration with EDTA.
Equivariant neural networks and representation theory
Or: Beyond linear.
Abstract: Equivariant neural networks are neural networks that incorporate symmetries. The nonlinear activation functions in these networks result in interesting nonlinear equivariant maps between simple representations, and motivate the key player of this talk: piecewise linear representation theory.
Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
Micronuclei test.M.sc.zoology.fisheries.
Current Ms word generated power point presentation covers major details about the micronuclei test. It's significance and assays to conduct it. It is used to detect the micronuclei formation inside the cells of nearly every multicellular organism. It's formation takes place during chromosomal sepration at metaphase.
The debris of the ‘last major merger’ is dynamically young
The Milky Way’s (MW) inner stellar halo contains an [Fe/H]-rich component with highly eccentric orbits, often referred to as the
‘last major merger.’ Hypotheses for the origin of this component include Gaia-Sausage/Enceladus (GSE), where the progenitor
collided with the MW proto-disc 8–11 Gyr ago, and the Virgo Radial Merger (VRM), where the progenitor collided with the
MW disc within the last 3 Gyr. These two scenarios make different predictions about observable structure in local phase space,
because the morphology of debris depends on how long it has had to phase mix. The recently identified phase-space folds in Gaia
DR3 have positive caustic velocities, making them fundamentally different than the phase-mixed chevrons found in simulations
at late times. Roughly 20 per cent of the stars in the prograde local stellar halo are associated with the observed caustics. Based
on a simple phase-mixing model, the observed number of caustics are consistent with a merger that occurred 1–2 Gyr ago.
We also compare the observed phase-space distribution to FIRE-2 Latte simulations of GSE-like mergers, using a quantitative
measurement of phase mixing (2D causticality). The observed local phase-space distribution best matches the simulated data
1–2 Gyr after collision, and certainly not later than 3 Gyr. This is further evidence that the progenitor of the ‘last major merger’
did not collide with the MW proto-disc at early times, as is thought for the GSE, but instead collided with the MW disc within
the last few Gyr, consistent with the body of work surrounding the VRM.
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Anda.ppt
- 1. ANDA for generic drug ways & means of US registration for foreign drug Submitted by: Submitted to : Sishant Rav Divya Dr. Hafsa Ahmad M.Pharm First Year ( Pharmaceutics ) BBAU Lucknow 1
- 2. Contents Introduction Basic generic drug requirement Objective of ANDA Innovator Vs. Generic Comparson between NDA & ANDA Generic drug approval Hatch-Waxman act 1984 General provision of this act Broad outline for ANDA Information required for filing ANDA Patent Certification The Orange Book Review of ANDA References 2
- 3. DEFINITION of 'Abbreviated New Drug Application (ANDA)' A written request to the U.S. Food and Drug Administration (FDA’s CDER) office of generic drug, to manufacture and market a generic drug in the United States. Abbreviated New Drug Applications are “abbreviated” since they do not require the applicant to conduct clinical trials and require less information than a New Drug Application. If an ANDA is approved, the generic drug will be listed in the Orange Book, which lists all medicines the FDA has found to be safe and effective. 3
- 4. Basic Generic Drug Requirements Are Same active ingredient Same route of administration Same dosage form Same strength Same condition for uses Inactive ingredient already approved in similar NDA 4
- 5. Main objective of ANDA To reduce the price of drug. To reduce the time development. To increase the bioavailability. 5
- 6. Innovator & Generic S.N. Parameters Innovator (Brand ) Generic (Chemical ) 1 Active ingredient Same Same 2 Safety & Efficacy Same Same 3 Performance/standar ds Same Same 4 Cost More expensive Less Expensive 5 FDA inspection of manufacturing process Yes Yes 6 FDA received report of adverse reaction Yes Yes 7 FDA received drug labelling Yes Yes 6
- 7. Comparison between NDA and ANDA S.No. NDA ANDA 1 Application for New drug Application for Generic Drug 2 Take long time ( 12-15 Yrs. ) Take less time ( 1-2 Yrs. ) 3 More Expenditure of money Comparatively less 4 Cost of drug more Cost of drug less 5 Non-clinical & clinical study are essential Both are not essential 6 Bioavailability & Bioequivalence studies are essential Only Bioequivalence study essential 7
- 8. Generic Drug Approval In 1970 FDA established the ANDA For review and approval of generic version. Before 1978 generic product applicant were required to submit the complete safety & efficacy through Clinical Trial. Post 1978 generic product applicant were required to published report of such trial 8
- 9. Hatch-Waxman Act 1984 Hatch-Waxman commonly known as “Drug Price Completion & Patent Term restoration Act 1984 This act dealing with approval of Generic drug 9
- 10. General provision of the act Maintaining list of patent Only bioequivalence study required No need clinical trial Para-I,II,III and IV certification Bolar Provision Data exclusive period for new molecule entities Extension of the original patent term 10
- 11. Broad outline for ANDA Product must meet appropriate standards of Identity. Strength. Quality and Purity Efficacy and safety should be equivalent to brand product already established 11
- 12. Information required for filing ANDA Product’s formulation Manufacturer’s procedure Control procedure Testing Facilities Dissolution profile Labelling 12
- 13. Patent Certification While filling an ANDA, the generic manufacturer is required to one of the following four certification The subject of the reference brand name listed in the ORANGE BOOK 13
- 14. Certification Para I certificate: There is no patent for the drug listed in the orange book Para II certificate: Patent is listed but expired Para III certification : Patent is listed . Is valid but the generic wants approval to market the drug once the pertinent patent expires 14
- 15. Certification Para IV certificate: Is the most critical of all and gives to almost all the anti-competitive practices associated with the Hatch-Waxman amendments of the EED and C act 15
- 16. The Orange Book The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. For more information on the Orange Book including its history, 16
- 18. 18
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