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Regulatory Open Forum (17)

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Product Lifecycle (19)

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19 results found for "tags:"Product Lifecycle""

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Discussion Thread 4
New NDA under 505 b (2) pathway or a supplement to NDA

Anonymous
Member

Added 20-Apr-2023

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User Created NDA USA Professional Interests Product Lifecycle

Discussion Thread 3
Annual Reports for Discontinued Drug Product

Sector Pharmaceuticals Professional Interests Product Lifecycle User Created USA

Anonymous
Member

Added 02-Feb-2023

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Sector Pharmaceuticals Professional Interests Product Lifecycle User Created USA

Discussion Thread 2
RLD for a 505(b)(2) pathway for a new indication

Sector Pharmaceuticals Professional Interests Product Lifecycle User Created USA

Anonymous
Member

Added 02-Feb-2023

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Sector Pharmaceuticals Professional Interests Product Lifecycle User Created USA

Discussion Thread 1
Change in Sponsor / Marketing Authorization holder and managing inventory with change

Professional Interests Compliance Product Lifecycle Regional Interests North America

Himani Parikh

Added 15-Jan-2023

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Professional Interests Compliance Product Lifecycle Regional Interests North America

Discussion Thread 1
Change to a Drug Proprietary Name

Regional Interests North America Sector Pharmaceuticals Professional Interests Product Lifecycle

Anonymous
Member

Added 08-Nov-2022

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Regional Interests North America Sector Pharmaceuticals Professional Interests Product Lifecycle

Discussion Thread 3
New Formulation Approval for Generic Drug Product

Professional Interests Chemistry, ... Product Lifecycle Regional Interests North America

Anonymous
Member

Added 08-Nov-2022

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Professional Interests Chemistry, ... Product Lifecycle Regional Interests North America

Discussion Thread 2
Market complaint - rate limit

Professional Interests Product Lifecycle Quality Assurance ...

Maria Pinto

Added 09-Dec-2021

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Professional Interests Product Lifecycle Quality Assurance ...

Discussion Thread 8
US- How long should the drug substance manufacturer maintain its Drug Establishment Registration with FDA

Regional Interests North America Sector Pharmaceuticals Professional Interests Product Lifecycle

Anonymous
Member

Added 12-Jul-2021

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Regional Interests North America Sector Pharmaceuticals Professional Interests Product Lifecycle

Discussion Thread 5
GTIN and stock code

Professional Interests Advertising, ... Product Lifecycle Regional Interests Global

Anonymous
Member

Added 29-Apr-2021

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Professional Interests Advertising, ... Product Lifecycle Regional Interests Global

Discussion Thread 2
Document Archiving Requirements for FDA, MDR EU and Health Canada

Regional Interests Europe North America Professional Interests Product Lifecycle

Nadine Adia

Added 20-Apr-2021

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Regional Interests Europe North America Professional Interests Product Lifecycle

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Discussion Thread 4 New NDA under 505 b (2) pathway or a supplement to NDA

Discussion Thread 3 Annual Reports for Discontinued Drug Product

Discussion Thread 2 RLD for a 505(b)(2) pathway for a new indication

Discussion Thread 1 Change in Sponsor / Marketing Authorization holder and managing inventory with change

Discussion Thread 1 Change to a Drug Proprietary Name

Discussion Thread 3 New Formulation Approval for Generic Drug Product

Discussion Thread 2 Market complaint - rate limit

Discussion Thread 8 US- How long should the drug substance manufacturer maintain its Drug Establishment Registration with FDA

Discussion Thread 5 GTIN and stock code

Discussion Thread 2 Document Archiving Requirements for FDA, MDR EU and Health Canada

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Discussion Thread 4
New NDA under 505 b (2) pathway or a supplement to NDA

Discussion Thread 3
Annual Reports for Discontinued Drug Product

Discussion Thread 2
RLD for a 505(b)(2) pathway for a new indication

Discussion Thread 1
Change in Sponsor / Marketing Authorization holder and managing inventory with change

Discussion Thread 1
Change to a Drug Proprietary Name

Discussion Thread 3
New Formulation Approval for Generic Drug Product

Discussion Thread 2
Market complaint - rate limit

Discussion Thread 8
US- How long should the drug substance manufacturer maintain its Drug Establishment Registration with FDA

Discussion Thread 5
GTIN and stock code

Discussion Thread 2
Document Archiving Requirements for FDA, MDR EU and Health Canada