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Biotechnology The United States Food and Drug Administration

Wrap-Up of Federal and State Chemical Regulatory Developments, August 2017

by Bergeson & Campbell, P.C. on

Section 5 of the Toxic Substances Control Act (TSCA) addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper. The Frank R. Lautenberg Chemical Safety for the 21st Century Act...more

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

NAS Publishes Report On Preparing For Future Products Of Biotechnology

by Bergeson & Campbell, P.C. on

On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a...more

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Releases Final Test Guideline For Performance Against Bed Bugs: On June 14, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of a final test guideline, Laboratory Product...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

NAS Releases Final Report on Preparing for Future Products of Biotechnology

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...more

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - Lynn L. Bergeson, Environmental Quality Management, Winter 2016: On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The law substantially...more

21st Century Cures: What's In the Box?

by Mark Mansour on

One of FDA’s most important tasks in the coming months will be the implementation of the 1,000 page long 21st Century Cures bill, enacted last year. We have assembled a quick, bullet-pointed summary of some of the major...more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align...more

Wrap-Up of Federal and State Chemical Regulatory Developments, April 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Denies TSCA Section 21 TBBPA Petition: On March 17, 2017, the U.S. Environmental Protection Agency (EPA) denied a Toxic Substances Control Act (TSCA) Section 21 petition submitted by, among others,...more

Politics, Medicine and Progress

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Boom Predicted in Biodegradable Stent Market

by Knobbe Martens on

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies

by Bergeson & Campbell, P.C. on

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future...more

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/NTP - Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” Bloomberg...more

NAS Issues Report on Preparing for Future Products of Biotechnology

by Bergeson & Campbell, P.C. on

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report: Preparing for Future Products of Biotechnology. Pursuant to the White...more

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

by Hogan Lovells on

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more

White House Releases Updated Coordinated Framework for the Regulation of Biotechnology

by Bergeson & Campbell, P.C. on

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...more

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

by Bergeson & Campbell, P.C. on

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...more

Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 - 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2016, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive...more

21st Century Cures: Modernizing Public and Private Research

by McDermott Will & Emery on

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

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