Regulatory Blog

According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...

The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting...

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...

USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....

Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry...

On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...

Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products....

Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...

This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...

US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...

The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...

On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...

Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...