Regulatory Focus™ > News Articles > The Regulatory Remainder: What We Missed Last Week (25 August)

The Regulatory Remainder: What We Missed Last Week (25 August)

Posted 25 August 2014 | By Alexander Gaffney, RAC

The Regulatory Remainder: What We Missed Last Week (25 August)

Try as we might here at Regulatory Focus, we occasionally set a piece of information aside with the intention of writing about it more fully, only to never get around to doing so. That's especially true during the summer when we take a few half-days off from work and return to a mountain of interesting things about which to write and not nearly enough time to do so.

So without further interruption, here's a brief recap of some of the items we had fully intended to cover this week and last, but never had time to get around to.


Generic Pharmaceutical Companies Seek Entry into ICH

Last week the International Generic Pharmaceutical Alliance (IGPA), a trade group consisting of pharmaceutical companies, wrote to the International Conference on Harmonization's (ICH) steering committee. IGPA is reportedly seeking entry into the pharmaceutical harmonization group, which now includes FDA, EMA, Japan's MHLW, and the pharmaceutical trade groups EFPIA, PhRMA and the Japan Pharmaceutical Manufacturers Association (JPMA).

ICH presently lacks any generic pharmaceutical members—a sticking point for some global regulators, which have recently viewed harmonization attempts by ICH with suspicion (i.e. advancing the causes of branded pharmaceutical products at the expense of generic pharmaceuticals. (Read More)

FDA Off to a Quick Start on Drug Approvals

FDA approved 17 new drugs through the first half of 2014. The total now sits at 26, putting FDA more or far exceed last year's total of 27 new drugs approved, and on pace to meet its 2012 total of 39 new drugs approved. (Read More) (EP Vantage Report)

New Money for Orphan Drug Projects

Did you forget that FDA funds projects to accelerate development of orphan drugs? In case you did, FDA's out with a new notice this week indicating that it plans to spend $14.1 million in FY2016, of which $4.1 million will be for between five and ten new projects. The other $10 million will go toward funding existing projects, FDA said. The agency said it hopes to maintain its level of funding in the coming years as well. (Read More)

Council on Foreign Relations Weighs in on Drug Quality

The Council on Foreign Relations generally isn't a group you hear too much about on matters of drug regulation, but this week the influential think tank weighed in on drug quality. In a white paper posted to the group's website, it discusses attempts to facilitate a harmonized, mutually-reliant approach to global drug regulation, and how FDA is "ideally positioned to facilitate a multilateral coalition composed of heads of medicines agencies."

The paper calls for any harmonization efforts to be narrow in their scope, flexible, involving select members, and including non-governmental entities and regulators. (Read More)

Workshop on Brain-Computer Interfaces

Ever get the sense that you're living in the future? FDA's notice that it will hold a meeting on brain-computer interfaces is probably as good an indication that you are as any. The upcoming meeting will focus on so-called neuroprostheses that allow patients who have lost the ability to naturally control parts of their body to function.

"The purpose of this workshop is to obtain public feedback on scientific, clinical, and regulatory considerations associated with BCI devices," FDA explains in its announcement. (Read More)

New Advisory Committee Members

FDA's advisory committees are hugely influential in deciding whether a product is or is not approved by regulators. The agency is now recruiting 11 new members for several of its advisory committees, of which four will be voting members and the other 7 will be non-voting members of the committees. (Read More)

The agency has also renewed the charters of many of its Advisory Committees, which was expected. (Read More)

FDA Removes Some Biologics Testing Requirements

This week FDA announced that it will amend the biologics regulation to remove some "general safety test" (GST) requirements for biological products. The agency said the current regulations are duplicative, and are already contained within Biological Licensing Applications (BLAs). (Read More)

The agency is also now out with a new guidance on assessing the immunogenicity of therapeutic protein products. (Read More)

FDA's UDI Small Entity Compliance Guide

Are you a small device company? FDA wants to give you a hand with UDI compliance with a new guidance document, UDI System: Small Entity Compliance Guide. In case you've been living under a rock all year or are just new to regulatory affairs, this is well worth a read.

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