The document discusses the Hatch-Waxman Act and its role in facilitating generic drug approvals in the US. It introduced the Abbreviated New Drug Application (ANDA) process which allows generics to piggyback on the clinical trial data of branded drugs. The Act also established the Orange Book database which lists drug patents. Generic companies can file ANDAs with certifications (Paras I-IV) regarding the patents. Para IV filings are the most complex and involve claims of non-infringement or patent invalidity, often leading to litigation between generic and branded companies. The Act aimed to balance increased generic competition with incentives for continued drug innovation.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
Abbreviated New Drug Application [ANDA]Sagar Savale
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.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
Abbreviated New Drug Application [ANDA]Sagar Savale
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.
Anda submission and paragraph IV certificationRichaTrivedi16
Anda submission and paragraph IV certification covers topic goals of anda , innovator/generic difference ,hatch waxman act , ANDA certification clauses , Anda review pathway , comparison of diffirent pathway
The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Anda submission and paragraph IV certificationRichaTrivedi16
Anda submission and paragraph IV certification covers topic goals of anda , innovator/generic difference ,hatch waxman act , ANDA certification clauses , Anda review pathway , comparison of diffirent pathway
The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Hatch- waxman act (The drug price competition and patent term restoration act...Mohit Kumar
The Drug Price Competition and Patent Term Restoration Act , informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.
This document contains the mostly asked questions for the job interviews of drug regulatory affairs which will help the candidate ace the interview with ease
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This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
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Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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Para i iv orange book
1. P. ILANANGAI IP CONSULTANT ALTACIT GLOBAL CHENNAI PARA I, PARA IV, ORANGE BOOK
2. INTRODUCTION As the world moves closer to the concept of a 'global village' by reduction and elimination of trade barriers, new challenges crop up. A case in point is the market for Generic Drugs (Drugs which are free from patent protection or not covered under patents). It was felt that since 95% of the drugs being marketed in India were generics, introduction of a new IPR regime would not affect prices. Rather it was felt that the benefits were more-Indian Companies could license out new technologies and also tap global markets for their products. Indian Pharmaceutical companies enjoyed two 'homegrown' advantages viz. much cheaper manufacturing facilities and world-class medicinal chemistry skills. contd..
3. Prior to 1962, as per Federal Food, Drug and Cosmetic Act, all application for registration were examined on the basis of the safety profile. But for manufacturing of generic, there were also the requirement of the clinical data to prove efficacy. Then after, Kefauver- Harris amendment was done in FDC Act in the year of 1962. As per this amendment, proof of efficacy was also required along with the safety profile. contd..
4. To overcome the drawback of Kefauver- Harris amendment, in year of 1984, Drug Price Competition and Patent Term Restoration act was implemented in FDC act, also known as Hatch-Waxman act. "The Hatch-Waxman Act is an act dealing with the approval of generic drugs and associated conditions for getting their approval from the Food and Drug Administration (FDA), market exclusivity, rights of exclusivity, patent term extension and Orange Book Listing." contd…
5. THE ACT WAS ENACTED BY THE FOLLOWING OBSERVATIONS: There were no generic drugs in market for 150 off patent drugs. Manufacturers were not interested to manufacture cheaper generic versions because of stringent regulatory procedures. Drug companies were not interested to waste time and money on clinical trials of generic drugs, because of fewer profits from those cheaper generics and more stringent regulations. The Hatch-Waxman Act focused these issues and proposed many changes and started the generic drugs approval procedure as Abbreviated New Drug Application (ANDA), for the purpose of market authorization.
6. ORANGE BOOK Each holder of an approved new drug application (NDA) must list pertinent patents it believes would be infringed if a generic drug were marketed before expiration of these patents. The FDA maintains a list of such patents in its publication, Approved Drug Products with Therapeutic Equivalence Evaluations commonly known as Orange Book. Purpose: To make generic pharmaceutical firms aware of patents protecting brand-name drugs All patents that claim a new drug, or some method of using this drug are listed in the Orange Book. contd..
7. Electronic Orange Book (EOB) is updated daily providing product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic products which is important for substitution purposes. The EOB content includes: New Drug Application (NDA) approvals. NDA application numbers are preceded with “N” Abbreviated New Drug Application approvals (ANDA or Generic). Generic application numbers are preceded with “A”.
8. GENERIC DRUGS A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. Generics are considered (by the Food and Drug Administration (FDA)) identical in dose, strength, route of administration, safety, efficacy, and intended use. The costs of these generic drugs are so low that many developing countries can easily afford them. For example, Thailand has imported millions of doses of a generic version of the blood-thinning drug Plavix (used to help prevent heart attacks), at a cost of 3 US cents per dose from India, the leading manufacturer of generic drugs. Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples.
9. GENERIC DRUGS CAN BE LEGALLY PRODUCED FOR DRUGS WHERE: 1) the patent has expired, 2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where a patent(s) is/are not in force.
10. FILING FOR GENERIC DRUGS Who can file? Any person could file an ANDA for a drug approved under § 505(b) of the Federal Food, Drug, and Cosmetic Act Requirements Same active ingredient Same conditions of use (labeling) Same dosage form Same strength Same route of admin Bioequivalent Patent Certification
11. FOUR POSSIBLE CERTIFICATIONS[PARAS] The generic approval process is called Abbreviated New drug Application (ANDA). While filing an ANDA, the generic company has to choose one of the following four options (referred to as paras) A Para I filing is made when the innovator has not made the required patent information in the Orange Book. A Para II filing for the launch of a generic drug is made when the drug is already off patent. A Para III filing is made when the patent for the product exists but the generic company wants to enter the markets after the date of patent expiry passes. A Para IV filing is made when the ANDA applicant believes its product or the use of its product does not infringe on the innovator's patents listed in the Orange Book or where the applicant believes such patents are not valid or enforceable.
12. PARA IV FILING Drugs are necessity in ailments. But sometimes the drug prescribed may be costly and may not be affordable for patients. In such a scenario, generic companies manufacturing the same costly drugs at affordable price are a boon for the patients. But this involves infringement of patents of the innovator. To serve the patients with affordable drugs, several companies have adopted the route of Para IV filings.
13. PROCESS In all the generic filings, the FDA has 180 days to deem the generic application complete and accept it for review, or incomplete and reject for filing. In case of Para I and Para II filing, once the application is deemed complete, it is simply processed for approval. In case of Para III the application is processed for approval, however its approval status depends upon the products patent expiry. Apparently Para IV filings are the most lucrative, tedious, time consuming and expensive of the above.
14.
15. Large pharmaceutical companies often spend millions of dollars protecting their patents from generic competition. Apart from litigation, companies use other methods such as reformulation or licensing a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are known as authorized generics. They are not affected by the 180 day exclusivity period as they fall under the patent holder's original drug application.
16. Prime example is Simvastatin (Zocor), a popular drug created and manufactured by U.S. based pharmaceutical Merck & Co., which lost its US patent protection on June 23, 2006. India-based Ranbaxy Laboratories (at the 80 mg strength) and Israel-based Teva Pharmaceutical Industries (at all other strengths) received 180 day exclusivity periods for Simvastatin; due to Zocor's popularity, both companies began marketing their products immediately after the patent expired. However, Dr. Reddy's Laboratories also markets an authorized generic version of Simvastatin under license from Zocor's manufacturer, Merck & Co.; some packages of Dr. Reddy's Simvastatin even show Merck as the actual manufacturer and have Merck's logo on the bottom.
17. Drug makers in Para IV Litigation Hoffman – La Roche has slapped a lawsuit at Indian generic drug maker Orchid Chemicals & Pharmaceuticals Ltd. over a newly issued patent for Roche's blockbuster osteoporosis drug Boniva. The US Patent was issued (US Patent 7410957 - Method of treatment using bisphosphonic acid) on August 12, 2008 and Orchid had filed an ANDA (Abbreviated New Drug Application) with the USFDA under Para IV of the Hatch-Waxman Act. Interestingly, Orchid was sued in September last year over the alleged infringement of another patent of Boniva by Roche. Orchid was accused of infringing US Patent 7192938 (US Patent Issued on March 20, 2007) following its paragraph IV ANDA submission to manufacture a generic version of Boniva.
18. AstraZeneca blocks Sun Pharma's Para IV filing on Nexium AstraZeneca filed two separate cases against Sun Pharma. The MNC seeks to block Sun Pharma from selling an intravenous (IV) version of Nexium ,a medicine for ulcer (esomeprazole magnesium), its largest selling drug, in the US before 2014. Approved by the US Food and Drug Administration (FDA) in 2005, Nexium's patents are valid in the US till 2014. With global sales of close to $5 billion (Rs 22,907 crore), the drug had sales of $2.84 billion (Rs 13,011 crore) in the US market in 2009.
19. CONCLUSION The Hatch-Waxman act act has changed the scenario of pharma industry by providing various provisions for generic as well as branded drug manufacturer and also helped to make available low cost drug therapy.