glenmark pharmaceuticals ltd., pithampur, india 5.24.18 483 · arsen karapetyan, investigator dedi...

7

Upload: vanngoc

Post on 26-Apr-2019

230 views

Category:

Documents

1 download

Report

Download

Embed Size (px):

TRANSCRIPT

Page 1: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Page 2: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Page 3: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Page 4: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Page 5: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Page 6: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Page 7: Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483 · Arsen Karapetyan, Investigator Dedi cated Drug Cadre Pratik S Upadhyay, Generic Drug User Fee x Amendments (GDUFA) PREVIOUS

Day2.2 - Lionberger - GDUFA Regulatory Science

GDUFA II: Requests for Reconsideration · 2017-11-08 · The OGD Office of Regulatory Operations Associate Director will ... – Cover letter identifies submission as a ... • Provide

Exhibit 99 (5.24.18) - Q1 FY19 Earningss2.q4cdn.com/785564492/files/doc_financials/2019/q1/Best-Buy-Report… · Title: Exhibit 99 (5.24.18) - Q1 FY19 Earnings.pdf Author: a813704

Generic Drug User Fee Act Reauthorization GDUFA II

Office of Generic Drugs (OGD) Update on GDUFA … Office of Generic Drugs (OGD) Update on GDUFA Implementation . Kathleen Uhl, MD . Director, Office of Generic Drug . CDER/FDA . GPhA

How GDUFA Could Kill Your US Business Plan

Completeness Assessment for Type II DMF Under GDUFA · Wei Song, Ph.D . DMF Review Staff . OGD/OPS/CDER . Completeness Assessment for Type II DMF Under GDUFA

Drug Requirements/ Drug Name Drug Requirements/ Tier

GDUFA: Evolving Quality Assessment - Generic ...€¢OPS SOP 2501: Process for Issuing Deficiencies and Information Requests for Generic Drug Chemistry Review (real time communication),

GDUFA Research Update on Mechanistic Modeling Approaches

The GDUFA II Pre-ANDA Program for Complex …...• The Pre-ANDA Program was established by GDUFA II – To clarify regulatory expectations for prospective applicants early in product

Day1.6 - Zhang - DMFs With a GDUFA Perspective

Guidance for Industry: ANDA Submissions Amendments and Easily Correctable Defeciencies Under GDUFA

Implementation of the Generic Drug User Fee … of the Generic Drug User Fee Amendments of 2012 (GDUFA) Testimony of Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research

DRUG MASTER FILES UNDER GDUFA: DMF Basics - FDA...on DMF Web site. (See Slide 3) Pregned Number -assi A pre-assigned number is required for an EDMF. May also be obtained for paper

U.S. FDAbec-global.com/.../2019/03/Farmaforum-2019-US-FDA.pdf · 12/31/2018 · Summary of GDUFA Program Over the five years of the first GDUFA program, from FY 2013 - 2017, FDA

ANDA Submissions — Amendments to Abbreviated New Drug ...zy.yaozh.com/sda/UCM578371.pdf · Abbreviated New Drug Applications Under GDUFA Guidance for Industry . DRAFT GUIDANCE This

DRUG MASTER FILES UNDER GDUFA: DMF Basics · List of all technical and administrative changes reported since last AR If no changes, ... DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur

GDUFA Regulatory Science Update (PDF - 2517KB)

FDA/GPhA Quarterly Meeting on GDUFA Implementation · Meeting Agenda. I. Introductions All . II. Communications Transparency FDA III. GDUFA Hiring Update FDA IV. ... OSIS: REFERENCES

FDA Testimony - Implementation of GDUFA (2!4!16)

The Direct Support Workforce: A crisis or serious …nisonger.osu.edu/.../05/Hewitt-Nisonger-5.24.18-handout-version.pdf · LTSS in a single word - UNCERTAINTY • Healthcare reform

ORANGEPAPER - Optimity Advisors · the generic industry, the FDA leverages the user fees collected from manufacturers, in accordance with the Generic Drug User Fee Amendments (GDUFA),

Amendments to Original ANDAs and PASs Under GDUFA · PDF fileAmendments to Original ANDAs and PASs Under GDUFA ... •amendments to original ANDAs submitted ... application is close

Amendments and Easily Correctable Deficiencies Under GDUFA

STATE OF OGD - accessiblemeds.org · STATE OF OGD: Pivoting to GDUFA II Kathleen Uhl, MD Director, Office of Generic Drug ... Controlled Correspondence GDUFA Performance by FDA Receipt

Glenmark Pharmaceuticals Ltd., Pithampur, India 5.24.18 483...India In the past two years, your finn has initiated approximately sixteen (16) Incident repolts related to power outages

ANDA Submissions - Content and Format of Abbreviated New Drug · PDF fileANDA Submissions - Content and Format of Abbreviated New Drug Applications . Draft Guidance: Impact of GDUFA

Exhibit 99 (5.24.18) - Q1 FY19 Earnings...Title Exhibit 99 (5.24.18) - Q1 FY19 Earnings.pdf Author a813704 Created Date 5/23/2018 6:32:23 PM

Intracellular unbound drug concentrations€¦ · Keywords: intracellular unbound drug concentrations, free drug, drug binding, drug transport, drug accumulation, cellular drug response,

Dangerous Liaisons: Disclosure Drug-drug, drug-nutrient ...c.ymcdn.com/sites/ · Drug-drug, drug-nutrient interactions Monica Tombasco, MS, MSNA, ... –Absorption –Distribution

Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA

DRUG MASTER FILES UNDER GDUFA: DMF Basics · PDF file•Physical Media (CD-ROM, DVD or USB drive) –Holder sends the DMF on physical medium in eCTD format to the ... • Notify FDA

STATE OF OGD - Food and Drug Administration · STATE OF OGD: Pivoting to GDUFA II ... 223 192 225 241 290 266 245 239 249 269 230 229 243 225 227 278 ... GDUFA PAS Goal

Drug Name Drug Requirements/ Drug Name Drug Requirements