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USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages
The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...
Sharan Murugan
May 22, 20221 min read
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...
Sharan Murugan
May 22, 20221 min read
Guidance on Clinical Trial Applications -
The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting...
Sharan Murugan
May 18, 20221 min read
Generic Drug User Fee Guidance - Assessing User Fees - USFDA
The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...
Sharan Murugan
May 18, 20221 min read
USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....
Sharan Murugan
May 17, 20221 min read
EMA's IRIS Guide for Applicants - On How to Create & Submit Scientific Applications
Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry...
Sharan Murugan
May 17, 20221 min read
SwissMedic - Technical Requirements for the Submission of Clinical Trial Application
On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...
Sharan Murugan
May 13, 20221 min read
SFDA - Guidelines for Variation Requirements
On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...
Sharan Murugan
May 13, 20221 min read
USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...
Sharan Murugan
May 11, 20221 min read
SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product
South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products....
Sharan Murugan
May 8, 20221 min read
Guide to Clinical Trials conducted under the CTR in Ireland
Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...
Sharan Murugan
May 8, 20221 min read
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...
Sharan Murugan
May 2, 20221 min read
USFDA Guidance on Electronic PostMarketing Safety Reporting
US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...
Sharan Murugan
May 2, 20221 min read
Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA
The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...
Sharan Murugan
May 2, 20221 min read
SFDA's Product Classification Guidance
On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...
Sharan Murugan
Apr 24, 20221 min read
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...
Sharan Murugan
Apr 24, 20221 min read
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...
Sharan Murugan
Apr 17, 20221 min read
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
Sharan Murugan
Apr 17, 20222 min read
FDA's MAPP on Complex Product Classification for Generic Development
On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...
Sharan Murugan
Apr 17, 20221 min read
HPRA Guide to Parallel Imports of Human Medicines - Ireland
The Health Products Regulatory Authority (HPRA) updated its guidance on "Parallel Imports of Human Medicine" last week. Parallel...
Sharan Murugan
Apr 17, 20221 min read