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Focus on Regulation Blog

Articles: 1-10 of 338

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

USA - November 8 2018 On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes…

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

USA - November 7 2018 On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical…

EMA warns marketing authorisations holders to notify type I variations earlier

European Union - November 5 2018 On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary…

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

USA - November 5 2018 In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what…

Working up from Zero: Initial Negotiations on the “Zero Draft” treaty on Business and Human Rights

Global - October 31 2018 The UN intergovernmental working group tasked with developing a binding international treaty on business and human rights recently concluded its…

FDA aims to harmonize its human subject protection regulations with Common Rule

USA - October 29 2018 On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on…

A broader definition of “unmet needs” has been proposed to support the development of anti-bacterial medicinal products

European Union - October 25 2018 The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of…

Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

USA - October 25 2018 President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed…

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

USA - October 25 2018 On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for…

The new Belgian Biobank legislation will apply on 1 November 2018: are you ready?

Belgium - October 23 2018 The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19…