USA, FDA launched Guidance Snapshots

A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots.

These new Guidance Snapshots would be covering topics relating to modernizing drug clinical trials and accelerating drug development.

Three of these snapshots have been released so far. With 2 relating to recommendations on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing.

The 3rd is focused on developing targeted therapies in low-frequency molecular subsets of a disease.

These snapshots, which are about 2 to 3 pages long, would offer a detailed overview as well as recommendations.

The focus of this pilot program is to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents.

It is also warned by FDA that these snapshots should not be misinterpreted as a substitute for the actual guidance.

USA, FDA’s launch of purple book, an online database for biologics

The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database of biological product information.

The Purple Book will be updated weekly with newly approved biosimilar or interchangeable products, and their respective references being included within 10 working days. All functionality and all BLAs are expected to be available from August 2020.

Once the database is completed, it will allow easier searches to be made and offer information about all licensed biological products, including information ranging from product names, exclusivity, biologics license application submissions.

FDA to study Social Media Giant “Instagram” influencers and their disclosures.

It is confirmed that 2 studies would take place mainly focusing on Instagram influencers and how their audience perceive what they say and endorse.

This is part of OPDP’s efforts to better understand and relate to whether the presence of a disclosure of a payment status influences participant reactions.

As it’s evident that many celebrities and models often post a photograph of themselves alongside sponsored clothing or medicines.

It is important to have a disclosure on whether it is a paid advertisement alongside proper risk information for any posts involving consumable drugs or medication.

For both studies, the FDA said that they will manipulate the explicitness of the disclosure so it will be direct, indirect or absent.

The 1st study will be looking at an Instagram post for a fictitious endometriosis product and gauge followers’ perceptions and attitudes towards the product.

The 2nd study would focus on print direct-to-consumer (DTC) ads for a fictitious acne product. The effects of endorser type and payment disclosure would be their key focus of study.

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

Upcoming in the later part of 2020, we will see them move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests.

This new initiative would ease the process of making orphan drug designation requests, which are currently being physically mailed to the Office of Orphan Products Development (OOPD) on a CD, allowing an even connected information technology system alongside, advanced analytics and improvements in facilitating knowledge management.

Additionally, this change will provide external sponsors with an even more efficient submission of documents and enhanced direct communication directly with the FDA.