The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical procedures such as chromatographic assays (CC) and ligand-binding assays (LBA) that quantitatively determine the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin.  The templates in this guidance can be used for new drug applications (NDA), biologics license applications (BLA), and supplements to these applications to provide information regarding bioanalytical methods for pharmacokinetic assessments.

Tags: FDA

 

By Lynn L. Bergeson

The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media. EPA is accepting comments on the draft GFI until November 29, 2019, before it starts working on the final version of it.

Tags: FDA

 

 

On September 11, 2019, from 12:00 p.m. to 1:30 p.m. (EDT), the Environmental Law Institute (ELI) will host a webinar titled “Genetic Engineering: The Good, The Bad, and The Necessary.” The webinar is designed to cover the vast possibilities offered by genetic engineering in a world where regulatory officials face increasing pressure to guarantee global food security. Along with the many possibilities associated with genetic engineering, however, there are great concerns about the environmental, health, and ethical implications of it. Webinar panelists will discuss many of these possibilities and concerns.

Tags: ELI, GE

 

 

 

 

By Lynn L. Bergeson

On July 22, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) highlighted small businesses funding under the Small Business Innovation Research (SBIR) program. Having received $43.6 million in funding from DOE thus far, small businesses continue to grow as DOE announces Phase II awards. Last week, DOE announced Phase II Release grants that demonstrate commercial feasibility for innovations during the second phase of small businesses’ research. Nine EERE technology offices will fund 42 awards ranging from $975,000 to $1,150,000, with a two-year duration.

Tags: DOE, EERE, Research

 

By Lynn L. Bergeson

On July 22, 2019, the United Kingdom (U.K.) Department for Business, Energy and Industrial Strategy and Department for Environment, Food and Rural Affairs announced an open consultation for the development of standards for biodegradable, compostable, and biobased plastics. The consultation welcomes views from any interested parties to identify gaps and provide expert advice on:

  • The overall sustainability of biobased and biodegradable plastic products in comparison with other materials;
     
  • Existing relevant plastic degradation standards and how they are promoted without adverse environmental effects; and
     
  • The design and implementation of standards for biodegradable plastics to ensure they are fully biodegradable in a reasonable timeframe.

With a focus on obtaining robust evidence backed by scientific theory, direct practical experience, or analysis, rather than opinion, views from environmental scientists, bioscience or biotechnology practitioners, standards authorities, manufacturers, waste processors, consumers, producers, and certification authority experts are welcome. Consultation responses must be submitted by October 14, 2019. For further details, the call for evidence can be accessed here.


 

 
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