News & Analysis as of

Biotechnology The United States Food and Drug Administration

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative

by K&L Gates LLP on

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s...more

FDA Announces Meeting, Calls For Comments On FDA/USDA Agricultural Biotechnology Education And Outre

by Bergeson & Campbell, P.C. on

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...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Adopts 2017 NAICS Codes For TRI: On August 16, 2017, the U.S. Environmental Protection Agency (EPA) announced that it is updating the list of North American Industry Classification System (NAICS) codes...more

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

by Hogan Lovells on

Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

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

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