Category: Biopharma

FDA Drafts Guidance for Regulatory Submissions in Alternate Electronic Format

March 17, 2020
Biopharma

The US Food and Drug Administration (FDA) issued draft guidance providing recommendations on an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common...

TMDA Released Guidance on the Import of Research Products to Be Used in Clinical Research

March 5, 2020
Biopharma

Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the principles and procedures for the import of products to be used in clinical research studies conducted...

FAMHP: New Legislative Measures for Unavailable Medicines

March 5, 2020
Biopharma

This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages was...

USA: FDA Revises Guidance on Post marketing Studies and Clinical Trials

October 25, 2019
Biopharma

The US Food and Drug Administration (FDA) revised its draft guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21...

EU: EC Offers New Site Suitability Template under Incoming Clinical Trial Regulation

October 23, 2019
Biopharma

The European Commission (EC) published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which...

Regulatory Intelligence (RI) Unbolts all your Regulatory Challenges

July 12, 2019
Biopharma

Drug development has become highly complex than ever before since the globalization of the life sciences industry. Regulatory Intelligence (RI), which emerged about 15 years ago, is comparatively a...