David Horowitz on Biotechnology

New FDA pilot offers expedited drug program sponsors expanded FDA meeting opportunities on manufacturing issues

Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to provide...more

11/23/2022 / Biotechnology , Federal Pilot Programs , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

7/6/2022 / Abbreviated New Drug Application (ANDA) , Biotechnology , Comment Period , Food and Drug Administration (FDA) , Life Sciences , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Top 10 things biotech employers need to know about COVID-19 vaccines and returning to the office

On February 2, Hogan Lovells partners Melissa Bianchi, David Horowitz, and George Ingham presented a webinar to the Biotechnical Innovation Organization (BIO) on “What Biotech Employers Need to Know about COVID Vaccines and...more

2/16/2021 / Biotechnology , Coronavirus/COVID-19 , Disability Discrimination , Employee Rights , Employer Liability Issues , Employment Policies , Health and Safety , Infectious Diseases , Life Sciences , Pharmaceutical Industry , Vaccinations , Workplace Safety

Election 2020 Snapshot: Impacts of the U.S. election for the life sciences and health care industry

On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more

12/1/2020 / Affordable Care Act , Biden Administration , Biotechnology , China , Coronavirus/COVID-19 , Drug Pricing , FDA Approval , Healthcare Reform , Infectious Diseases , Life Sciences , Operation Warp Speed , Presidential Elections , Trans-Pacific Partnership , US Trade Policies , Vaccinations

Trump administration reversal would take away FDA’s authority to approve biosimilars

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

7/15/2020 / Affordable Care Act , Biologics , Biosimilars , Biotechnology , BPCIA , Constitutional Challenges , Department of Justice (DOJ) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs , SCOTUS , Severability Doctrine , Tax Cuts and Jobs Act , Trump Administration

The global impact of COVID-19 on clinical trials and countermeasure development

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Life Sciences and Health Care Horizons - 2020

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

7/23/2019 / Biotechnology , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Healthcare Reform , Imports , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Regulatory Oversight , Regulatory Standards , Rulemaking Process , Secretary of HHS , Supply Chain , Working Groups

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more

6/25/2019 / Biotechnology , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Regenerative Medicine , Regulatory Agenda , Regulatory Standards , Stem cells

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

4/26/2019 / Biotechnology , Draft Guidance , Emergency Management Plans , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Medical Devices , Pharmaceutical Industry , Product Recalls , Regulatory Oversight , Strategic Planning

Life Sciences and Health Care Horizons - 2019

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

3/18/2019 / Artificial Intelligence , Asia , Biologics , Biotechnology , Data Breach , Digital Health , Information Technology , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Supply Chain

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

3/13/2019 / Biotechnology , Food and Drug Administration (FDA) , Health and Safety , Over-the-Counter Sales , Personal Care Products , Pharmaceutical Industry , Proposed Rules , Public Health , Regulatory Oversight , Regulatory Requirements , Rulemaking Process

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general...

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more

11/8/2018 / Biotechnology , Department of Defense (DOD) , Expedited FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Memorandum of Understanding , Military Service Members , Pharmaceutical Industry , Prescription Drugs , Priority Rules , Regulatory Requirements

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