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The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs. According to the item, “[t]here are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials.” CDER conducted a series of risk assessment and risk management exercises concerning...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs.

Bergeson & Campbell, P.C. (B&C) is pleased to announce that Lara A. Hall, a Registered Quality Assurance Professional in Good Laboratory Practice with a Masters degree in Biology, has joined our staff of scientists at B&C, The Acta Group (Acta), and B&C Consortia Management, L.L.C. (BCCM). With over a decade of experience in environmental research, study monitoring, and international regulatory support, Ms. Hall will assist our clients in placing and monitoring studies to assist...

This is the first in a series of updates concerning compliance initiatives underway by the U.S. Food and Drug Administration (FDA) that affect various segments of the regulated industry. This issue focuses on court actions, Warning Letters, recalls, and other matters pertaining to dietary supplements. We will periodically outline actions and issues affecting prescription and over-the-counter (OTC) drugs, medical device and diagnostic products, food, cosmetics, animal drugs, and biologics....

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific...

The FDA issues two new draft guidance documents on nanotechnology in food substances and cosmetics.

On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents on the use of nanotechnology in food and cosmetic products -- "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives," which is available online, and "Guidance for Industry: Safety of...

On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” and “Guidance for Industry: Safety of Nanomaterials in...

The April 6, 2012, issue of Bloomberg BNA Daily Environment Report quotes Lynn L. Bergeson regarding the Food and Drug Administration’s (FDA) recent decision to reject the Natural Resources Defense Council’s petition to ban the use of bisphenol A in food packaging.

Bergeson & Campbell, P.C. (B&C) and its consulting affiliates, B&C Consortia Management, L.L.C. (BCCM) and The Acta Group, L.L.C. (Acta), are pleased to announce the expansion of their capabilities in Asia. The Acta Group China, L.L.C. has formed a joint venture with Pacific Life Sciences Co. Ltd. (PLS), a leading Chinese firm serving the chemical industry with offices in Beijing, Shanghai, and Tanjin, China. This partnership broadens the firms' global capabilities in product...