Biotechnology The United States Food and Drug Administration

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Comment Deadline Approaches On Update To The Coordinated Framework For The Regulation Of Biotechnology

As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) Biobased and Renewable Products Update of September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Reg

On September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register ....more

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the...

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology," releasing two documents intended to modernize federal regulation of biotechnology...more

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to...more

EPA, FDA, and USDA Release Updates to Coordinated Framework on Biotechnology

On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents...more

PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications. Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed,...more

Agreement Reached on Bipartisan Federal GMO Food Labeling Bill

Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws - Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified...more

To be prepared is half the victory

In the second in our series of alerts relating to drug pricing, we identify several considerations and potential actions that a pharmaceutical or biotechnology company can take to address the current headwinds impacting...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

3D Printing and the Renaissance of Local Economies

The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

SEC Charges Biotech Company and Its Officers with Misleading Investors by Failing to Disclose FDA Concerns and Recommendations

On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more

NAS Releases Agenda for First Future Biotechnology Products and Regulatory System Committee Meeting

On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of...more

[Webinar] Avoiding Drug Substance Patents and Exclusivities: Prodrugs, Deuterated Drugs, and 505(b)(2) - April 14th, 9:00am...

Join Kurt Karst (Hyman, Phelps & McNamara, P.C.) (coauthor, "The FDA Blog") and Jeffrey Hovden (Robins Kaplan LLP) (coauthor, Generically Speaking) for a collaborative webinar. For generic drug companies, the biggest and...more

Sign Up For The Third And Final Public Meeting On Modernizing The Regulatory System For Biotechnology Products

On July 2, 2015, the Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality jointly issued Modernizing the Regulatory...more

Biotechnology: Academies to Study Future Products of Biotechnology

On March 18, 2016, the National Academies of Science, Engineering, and Medicine (The Academies) announced the appointment of its provisional committee on "Future Biotechnology Products and Opportunities to Enhance...more

Biotechnology: Case Studies of Hypothetical, Genetically Engineered Organisms Are Discussed at Second Meeting on Modernizing the...

On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6...more

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...more

More Information Available On Upcoming "Modernizing The Regulatory System For Biotechnology Products" Meetings

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the...more

Biotechnology: Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9

The second public meeting on the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products" will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is...more

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two...more

Dates And Locations Of "Modernizing The Regulatory System For Biotechnology Products" Meetings Announced

On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on...more

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled...more

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