№ lp_1_19202
File format: docx
Character count: 9110
File size: 42 KB
Guideline document on how to format and structure Pre-IND briefing packages for meetings with the FDA, with a focus on product development, regulatory pathways, and meeting objectives.
Year:
2023
Region / City:
United States
Subject:
Pharmaceutical Regulatory Guidance
Document Type:
Guidance
Organization / Institution:
FDA
Author:
FDA
Target Audience:
Industry stakeholders, Sponsors, Applicants
Effective Period:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Contextual Description
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2017
Region / City:
European Union
Topic:
eCall Service, Emergency Communication
Document Type:
Recommendation
Organization / Institution:
European Conference of Postal and Telecommunications Administrations (ECC)
Author:
Not specified
Target Audience:
National authorities, mobile network operators, vehicle manufacturers
Validity Period:
From 22 November 2017
Approval Date:
22 November 2017
Amendment Date:
December 2020
Year:
2023
Region / City:
Global
Topic:
Biopharmaceutical studies, bioavailability, bioequivalence
Document Type:
Regulatory Guidance
Agency / Institution:
FDA, EMA
Author:
Not specified
Target Audience:
Industry professionals in pharmaceuticals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Year:
2026
Region / City:
Global
Topic:
Clinical Efficacy Studies
Document Type:
Guidance
Author:
FDA
Target Audience:
Industry professionals in pharmaceuticals
Action Period:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Description:
Regulatory guidance on the structure and numbering of templates in eCTD submissions, with a focus on the proper organization and presentation of efficacy studies in pharmaceutical documentation.
Year:
2026
Region / city:
USA, Canada
Topic:
Active substance evaluation
Document Type:
Regulatory document
Organization:
Regulatory Authority (PMRA, EPA)
Author:
Applicant
Target Audience:
Regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2017
Region / City:
European Union
Theme:
eCall, Emergency Communication, Vehicle Safety, Numbering Resources
Document Type:
Recommendation
Institution:
European Conference of Postal and Telecommunications Administrations (ECC)
Author:
European Conference of Postal and Telecommunications Administrations
Target Audience:
National authorities, car manufacturers, mobile operators, PSAPs
Period of Validity:
Ongoing
Approval Date:
22 November 2017
Modification Date:
None
Year:
2020
Region / City:
Web meeting
Subject:
Minutes of the 21st WG NaN Meeting
Type of document:
Meeting minutes
Author:
Andrew Burns
Target audience:
Delegates representing CEPT administrations, ETSI, NTT, ECO
Period of validity:
15-17 December 2020
Date of approval:
15 December 2020
Date of amendments:
N/A
Year:
2018
Region / city:
The Hague, The Netherlands
Subject:
Meeting Report – PT FNI, Copenhagen
Source:
Chairman / Francesco Bernabei
Source e-mail:
[email protected]
Date of the document:
01 February 2018
Note:
Action items
Target audience:
PT FNI members
Action period:
2018
Context:
Report of the 36th PT FNI meeting, including discussions on the development of numbering strategies, work progress on number assignment, and preparations for upcoming conferences.
Year:
2025
Region / City:
International
Topic:
Document numbering system
Document Type:
Guideline
Organization / Institution:
ICCAT Secretariat
Author:
ICCAT Secretariat
Target Audience:
Delegations of CPCs
Period of validity:
2025
Approval Date:
N/A
Amendment Date:
N/A
Year:
2014
Region / City:
United States
Theme:
Fast Track Designation, Drug Development
Document Type:
Guidance
Organ / Institution:
FDA (Food and Drug Administration)
Author:
FDA
Target Audience:
Drug Sponsors, Pharmaceutical Industry
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2018
Region / City:
United States
Topic:
Regulatory Guidance, Clinical Trials, Investigational Product
Document Type:
Regulatory Guidance
Organization / Institution:
FDA
Author:
FDA
Target Audience:
Industry Professionals, Investigators, Clinical Research Teams
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2001
Region / city:
N/A
Subject:
Pharmacokinetics, Drug Development
Document type:
Regulatory guidance
Author:
N/A
Target audience:
Industry professionals, pharmaceutical companies
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2022
Region / city:
Global
Topic:
Safety Data, Drug Exposure, Clinical Trials
Document Type:
Regulatory Guidance
Organization:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Author:
Unknown
Target Audience:
Pharmaceutical Industry Professionals, Regulatory Authorities
Effective Period:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Year
Year:
N/A
Region / City:
N/A
Subject:
Pharmaceutical Documentation, eCTD
Document Type:
Regulatory Guidance
Organization / Institution:
FDA
Author:
N/A
Target Audience:
Pharmaceutical Industry
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Note:
Year
Topic:
Wastewater Regulation
Document Type:
Form
Year:
2026
Region / City:
Global
Topic:
Regulatory Compliance, Certification
Document Type:
Notification Form
Organization / Institution:
SGS
Author:
SGS
Target Audience:
Clients holding SGS certification
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Contextual Description:
A form for notifying SGS of any changes or regulatory actions affecting the validity or scope of certification for medical devices.
Year:
2021
Region / City:
West and Central Africa
Topic:
Electricity, Governance, Institutional Strengthening, Africa
Document Type:
Report
Organization:
European Union, African Union Commission
Author:
Dr. Dimitris Papastefanakis, Dr. William Gboney, Dr. George Kyriakarakos, Mr. Jian Bani
Target Audience:
Policy makers, energy sector professionals
Period of Validity:
2021-2040
Approval Date:
August 31, 2021
Date of Revisions:
N/A
Note:
Year