Regulatory Blog

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

Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...

The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...

Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...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

Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...

Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...

Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...

Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions...

Recently on 4th January, 2023 the Philippines Food and Drug Administration (FDA) released a draft guideline for comments i.e;...

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...