The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
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.
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.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
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.
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.
This presentation will address Refuse to Receive standards when Submitting ANDAs and Prior approval supplements (PASs) to ANDAs. The presentation highlights deficiencies that may cause FDA to refuse-to-receive an ANDA.
Regarding the objectives of the act , drug approval that includes both the branded drug and the generic drug approval, new drug exclusivity, about the challenging patent exclusivity, patent term extension and patent litigation under the act ,and the benefits of branded manufacturers will be discussed here .
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the patent provisions of the 1984 Hatch-Waxman Act
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
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.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
1. By:
DEBANGSHU S. ROY
MBA P.M.
Hamdard University
2. 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.
Once approved, an applicant may manufacture and market the generic
drug product to provide a safe, effective, low cost alternative to the
public.
All approved products, both innovator and generic, are listed in
FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations (Orange Book).
2
3. INNOVATOR VS GENERICS
S.N. PARAMETERS INNOVATOR DRUG GENERIC DRUG
1. Active ingredients Same Same
2. Safety & efficacy Same Same
3. Quality & strength Same Same
4. Performance and standards Same Same
5. Costs/prescription Highly expensive Less expensive
6. FDA inspection of
manufacturing facilities Yes Yes
7. FDA reviews reports of
adverse reactions Yes Yes
8. FDA reviews drug labeling Yes No
9. Extensive research and
development investments Yes No
10. Expensive marketing &
advertising Yes No
11. Patent protection Yes No
12. FDA review to show active
ingredient is equivalent to original NA Yes
13. Product Development Time ~ 12 yrs 2- 4 yrs
3
4. Generic Drug Approval
In 1970 FDA established the ANDA as a mechanism for the review and
approval of generic versions.
Before 1978, generic product applicants were required to submit complete
safety and efficacy through clinical trials.
Post 1978, applicants were required to submit published reports of such
trials documenting safety and efficacy.
Neither of these approaches was considered satisfactory and so originated
Hatch Waxman Act on 1984.
4
5. Indispensability Grounds
For Generics
Contain the same active ingredients as the innovator drug (inactive ingredients
may vary).
Must be identical in strength, dosage form, and route of administration.
Must have same use/indications.
Must be bioequivalent.
Must have same batch requirements for Identity, Safety & Purity.
Must follow strict standards of FDA's GMPs.
5
6. Hatch-Waxman Act
Commonly known as “Drug Price Competition & Patent Term Restoration Act”
of 1984.
“The Hatch-Waxman Act is an act dealing with the approval of generic drugs
and associated conditions for getting their approval from FDA, market
exclusivity, rights of exclusivity, patent term extension and Orange Book Listing.”
Necessitated By :
1. Absence of Generic drug manufacturing.
2. Cumbersome regulatory procedures.
3. Patients were denied the option of cheaper drugs.
6
7. General Provisions of the Act
1. Maintaining list of patents which would be infringed.
2. Only Bioavailability studies and not clinical trials needed for approval.
3. Para I, II, III and IV certifications.
4. Data exclusivity period for New Molecular Entities.
5. Extension of the original patent term.
6. The “Bolar” Provision.
7
8. Recent additions to the Hatch-Waxman
Act
Under the “Medicare Prescription Drug and Modernization Act”, 2003:
1. Non-extension of the 30-month period.
2. Time limit for informing patent owner.
3. Provision for allowing declaratory judgment.
4. Benefit of exclusivity for several ANDAs filed on same day allowed.
8
10. PARA-I PARA-II
Required patent
information has not been Patent has expired
filed.
FDA may approve FDA may approve
generics generics
immediately, one or more immediately, one or more
applicants may enter. applicants may enter.
10
11. PARA-III PARA-IV
Patent not expired, will Patent is invalid or non
be expired on a specific infringed by generic
date. applicant.
FDA may approved ANDA
effective on the date of Generic applicant file
expiration, one or more notice to patent holder.
applicant may enter.
11
12. PARA IV CERTTIFICATION
After 45 days Patent
After 45 days Patent
Holder sues the
Holder doesn’t sue
Applicant 30months
applicant FDA may
stay granted to Patent
approve ANDA.
Holder.
ANDA Applicant granted
30 Months stay expired 30 Months stay not
approval.
expired.
For the first Applicant Subsequent approvals
the EMR of 180 days for EMRs are granted
starts with court’s after expiry of first
decision. applicant’s 180 days.
12
13. 30 Months stay not
expired
If judgement’s in favour Judgement favouring
of Patent Holder FDA ANDA EMR of 180
can not approve ANDA days begins for first
untill patent expiry. applicant.
First Applicant enters,
subsequent applicants
No entry occurs untill
enter only after expiry of
Patent Expiry.
EMR for the First
Applicant.
13
14. ANDA REVIEW PROCESS
APPLICANT
ANDA
ACCEPTABLE & REFUSE TO FILE-
COMPLETE NO LETTER ISSUED
YES
B.E. REVIEW CHEMISTRY/MICRO
REVIEW
REQUEST FOR PLANT
INSPECTION LABELING REVIEW
CHEMISTRY/LABELING
B.E. REVIEW ACCEPTABLE
YES REVIEW ACCEPTABLE
NO
NO
PREAPPROVAL INSPECTION NOT APPLICABLE
ACCEPTENCE
NO LETTER
B.E. DEFICIENCY LETTER
YES APPROVAL DEFERRED PENDING
SATISFACTORY RESULTS
ANDA APPROVED
14
15. The CTD Triangle
Regional
Admin.
Information
MODULE 1
Non Clinical Clinical
Quality overview Overview
Overall Non Clinical Clinical
summary Summary Summary
Quality Non Clinical Clinical
Report Report
MODULE 3 MODULE 4 MODULE 5
15
16. MODULES IN A CTD
MODULE I: Administrative and Prescribing Information
1.Table of Contents.
2.Includes data of Administrative Documents entailing:
Patent Information on patented product.
Patent Certifications.
Debarment certification.
3. Prescribing information like Package and container labels, packaging inserts,
patient leaflets, etc.
4. Labelling Comparison between Innovator and Generic drug.
16
17. MODULE II: SUMMARIES AND OVERVIEWS
1. Table of Contents.
2. Introduction to Summary Documents.
3. Overviews and Summaries: Module II should contain documents like:
M4Q: The CTD- quality
M4S: The CTD- safety
M4E: The CTD- efficacy
MODULE III: information on product quality
1. Table of Content.
2. Body of Data.
3. Literature Reference.
17
18. MODULE IV: NON CLINICAL STUDY REPORTS
Not required in ANDA Filing.
MODULE V: CLINICAL STUDY REPORTS
1. Table of Contents.
2. Study Reports including Case Report Forms and Case Report Tabulations.
18
19. RECOMMENDATIONS FOR e-CTD
1. PDF Files with version 3.0 of Acrobat Reader
2. Use of Embedded fonts in the Portable Document Format
3. A Print area of 8.5 inches by 11 inches and margin of 1 inches is ensured on
sides.
4. Scanned Documents should be avoided as Source Documents.
5. Hypertexts can be indicated by Blue-Texts or by rectangles using thin lines.
19
20. 6. Numbering on the PDF and Documents should be included as same.
7. Security or Passwords should not be included.
8. Full Indexes should be included.
9. Electronic Signatures may be added, Procedures are being employed for
archival of the same.
20
21. BIOEQUIVALENCE
A Generic drug is considered to be bioequivalent to Brand drug if:
Rate & extent of absorption do not show a significant difference from RLD.
Two drugs are said to be Bioequivalent if their Bioavailability after
administration in same dose are similar to a degree that there effects, with
respect to safety & efficacy can be expected to be the same.
21
22. NDA Vs ANDA Review Process
NDA REQUIREMENT ANDA REQUIREMENT
22
23. First-Time Generic Drug
Approvals - July 2011
Generic Drug Generic Brand Name Approval Date
Name Manufacturer
FONDAPARINUX SODIUM DR. REDDY'S ARIXTRA INJECTION 7/11/2011
INJECTION LABORATORIES LIMITED
ALFUZOSIN TEVA UROXATRAL EXTENDED- 7/18/2011
HYDROCHLORIDE PHARMACEUTICALS USA RELEASE TABLETS
EXTENDED-RELEASE
TABLETS
ALFUZOSIN SUN PHARMA GLOBAL UROXATRAL EXTENDED- 7/18/2011
HYDROCHLORIDE FZE RELEASE TABLETS
EXTENDED-RELEASE
TABLETS
PARICALCITOL SANDOZ CANADA, INC. ZEMPLAR INJECTION 7/27/2011
INJECTION
METRONIDAZOLE GEL TOLMAR INC. METROGEL 7/22/2011
23
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. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The 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.