Regulatory Blog

Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...

Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...

Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory...

Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...

Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...

In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...

Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...

The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...

Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...

Earlier today (09-January-2022), the Drug Regulatory Authority of Pakistan released an updated guidance on "Good Manufacturing Practices...

Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...

Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance information on the Innovative Licensing and...

Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products"....

The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...

A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...

Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...

Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...

Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...