Regulatory Blog

On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...

On 22-July 2022, USFDA released multiple guidance among them one is "Orange Book Questions and Answers Guidance for Industry. What is...

On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....

Clinical trials for Medicines: Apply for Authorisation in the UK (18 July 2022) This updated guidance will detail how to apply for a...

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with...

India's Ministry of Health and Human Welfare has released a draft proposal on 14th June, 2022 which suggests to add barcodes or quick...

The South African Health Products Regulatory Authority (SAPHRA) did a few Administrative updates and amendments in its Post-marketing...

Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...

FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...

Health Sciences Authority (HSA) updated its "GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE" recently, which describes the...

Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance Medicinal products with known...

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...

The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial...

As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...

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...