Guidance Documents

In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.

With just a short guidance document, the US Food and Drug Administration has redefined expectations for biosimilar applications by removing the typical need for comparative efficacy studies to support filings. Meanwhile, major moves on interchangeability are also on the horizon.

Alliance of Natural Health launches initiative to change FDA’s use of “significant scientific agreement” standard for allowing health claims with a citizen petition for approval of 118 nutrient-disease health claims.

NPA will learn not only if it will need to continue litigation seeking to force change should FDA reject its petition for deeming NMN a dietary ingredient, but also if agency acknowledges industry’s questions about the agency’s drug preclusion regulation.

NAD attorneys find Kendal Nutricare can continue using “natural” ad claims with limits for Kendamil formula but also conclude some research it submitted to support other claims wasn’t appropriate because the studies didn’t test its products.

Recommendations from the health technology assessment institute, NICE, reflect a strategic shift from treating type 2 diabetes to proactively preventing future complications of the condition.

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

Attorney Jonathan Emord says federal court’s grant of standing for Alliance for Natural Health USA and Meditrend to challenge FDA’s safety concerns about homeopathic drugs leaves open a door to continue arguing the agency violated multiple regulations by imposing NDA requirements for homeopathics.

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.