Search
Sharan Murugan
Jan 16, 20232 min read
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...
68 views0 comments
Sharan Murugan
Jan 8, 20231 min read
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal
Recently on 4th January, 2023 the Philippines Food and Drug Administration (FDA) released a draft guideline for comments i.e;...
25 views0 comments
Sharan Murugan
Jan 8, 20231 min read
Irelands HPRA's: Guide to Fees for Human Products
On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products"....
61 views0 comments
Sharan Murugan
Jan 4, 20231 min read
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...
48 views0 comments
Sharan Murugan
Dec 27, 20221 min read
Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product
A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...
40 views0 comments
Sharan Murugan
Dec 27, 20221 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
115 views0 comments
Sharan Murugan
Dec 27, 20222 min read
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
99 views0 comments
Sharan Murugan
Dec 15, 20221 min read
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...
48 views0 comments
Sharan Murugan
Dec 14, 20221 min read
USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program
Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...
22 views0 comments
Sharan Murugan
Dec 8, 20221 min read
USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations
Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...
82 views0 comments
Sharan Murugan
Dec 7, 20221 min read
USFDA Guidance: Homeopathic Drugs Products
Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic...
31 views0 comments
Sharan Murugan
Dec 6, 20221 min read
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
8 views0 comments
Sharan Murugan
Dec 2, 20221 min read
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
23 views0 comments
Sharan Murugan
Dec 2, 20221 min read
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...
110 views0 comments
Sharan Murugan
Nov 27, 20221 min read
South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File...
59 views0 comments
Sharan Murugan
Nov 27, 20222 min read
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...
60 views0 comments
Sharan Murugan
Nov 23, 20221 min read
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
44 views0 comments
Sharan Murugan
Nov 19, 20221 min read
USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...
32 views0 comments
Sharan Murugan
Nov 19, 20221 min read
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...
144 views0 comments
Sharan Murugan
Nov 19, 20221 min read
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...
26 views0 comments