№ lp_1_2_36254
File format: docx
Character count: 8507
File size: 34 KB
This document is a regulatory guidance for pharmaceutical sponsors on how to apply for fast track designation for drug development in response to serious conditions and unmet medical needs.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
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:
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
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:
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
Year:
2024
Region / City:
Not specified
Topic:
Professional designation examination
Document Type:
Examination paper
Organ / Institution:
PPRA
Author:
Not specified
Target Audience:
Candidates sitting for the professional designation examination
Period of Validity:
February 2024
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
European Union
Topic:
Medical Devices
Document Type:
Application Form
Authoring Organization:
Medical Device Coordination Group (MDCG)
Target Audience:
Conformity assessment bodies
Period of Validity:
Ongoing
Approval Date:
January 2025
Amendment Date:
N/A
Year:
2017
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Regulatory Document
Organization / Institution:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Notified Bodies, Conformity Assessment Bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2026
Organization:
Texas Department of Insurance
Document Type:
Amendment Proposal Form
Related Manual:
2026 Valuation Manual, VM-20
Sections:
9.F.3, 9.F.4, Appendix 2
Author:
Rachel Hemphill
Date Received:
10/28/25
Notes:
2025-15 VM-20, Section 9.F.3 and 9.F.4
Year:
2013
Region / City:
Washington, D.C.
Topic:
Foreign-Trade Zones (FTZ) Application
Document Type:
Instruction Sheet
Agency / Institution:
U.S. Department of Commerce, International Trade Administration
Author:
FTZ Staff
Target Audience:
Corporations and grantees applying for FTZ designation
Period of Action:
N/A
Approval Date:
March 2013
Amendment Date:
N/A