RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.
 

The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing. In the final version of guidance, ICH acceded to industry’s request to clarify ...

See More

The European Medicines Agency (EMA) has recommended that pholcodine-containing drugs be pulled from the European market after its experts agreed there was a significant risk of allergic reaction to neuromuscular blocking agents (NMBA). The recomme...

See More

Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars that have been introduced in the US recently had a stronger uptake than products ...

See More

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

See More

The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug...

See More

The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior...

See More

The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators, such as the US Food and Drug Administration (FDA) to be marketed in Switzerland. Currently, o...

See More

A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and interna...

See More

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

See More

The first three studies will look at the epidemiology of rare blood cancers to understand their prevalence in Europe; the use of the teratogenic epilepsy drug valproate; and the use of antibiotics to inform future work on antimicrobial resistance....

See More

The US Food and Drug Administration (FDA) recently warned a clinical trial sponsor for failing to submit an investigational new drug application (IND) for its drug-device combination eye treatment and failing to obtain approval from an Institution...

See More

Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on laser-assisted in situ keratomileusis (LASIK) patient labeling, arguing that the agency’s recommendations are based on ...

See More
Regulatory Focus Articles RSS Feed 2.0