All Knowledge & Insights By Date

By Lynn L. Bergeson From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing...

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W.  84 Fed. Reg. 18993.  The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and...

On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not...

By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...

By Lynn L. Bergeson In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods...

By Lynn L. Bergeson On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon.  In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S.  According to...

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Under the proposed rule, products that...

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  FDA notes that it has not established...

By Lynn L. Bergeson On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition...

By Lynn L. Bergeson On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation.  Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities: Advancing public health by promoting...

The National Nanotechnology Initiative (NNI) has published The National Nanotechnology Initiative Supplement to the President’s 2019 Budget.  The August 2018 document not only supplements the President’s budget request for fiscal year 2019, but also serves as NNI’s annual report and addresses the requirement for Department of Defense (DOD) reporting on its nanotechnology investments.  President Trump requests nearly $1.4 billion for NNI, “a continued investment in...

By Lynn L. Bergeson On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the...

On May 1, 2018, the Hawaii Senate and House of Representatives passed a bill that will ban the sale, offer of sale, or distribution in Hawaii of any sunscreen that contains oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider to preserve marine ecosystems, beginning January 1, 2021:  S.B. No. 2571, Environment; Water Pollution; Sunscreen; Oxybenzone; Octinoxate; Sale; Distribution; Prohibition.  The bill received unanimous...

On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present...

The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials.  The...

On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and OPP, will be holding two public meetings to discuss FDA’s Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina on November 7,...

By Lauren M. Graham, Ph.D. On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST).  FDA states the purpose of the public meetings is “to provide the public with...

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...

By Lynn L. Bergeson and Margaret R. Graham On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for...