On January 12, 2021, the U.S. Food and Drug Administration (FDA) published its Action Plan for further development of the Agency’s framework for regulatory oversight of artificial intelligence (AI) and machine learning (ML) based Software as a Medical Device (SaMD). The Action Plan identifies several opportunities for SaMD developers to…
In recent posts, we reviewed “down-rounds” and hedging COVID-19 pandemic risks in M&A. This post complements them and focuses on early-stage life sciences companies and their potential investors. While the customary development timelines for life sciences companies may seem less prone to risks associated with COVID-19, the pandemic still resulted…
As follow-up to our October post on pre-approval and pre-licensure inspections impacting U.S. Food and Drug Administration (FDA) drug and biologic approvals, this blog post discusses FDA’s recently announced temporary policy set forth in its December 2020 guidance on review timelines for company responses to a Complete Response letter (CRL)…
On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Read…
During the COVID-19 pandemic, M&A counsel and their respective life science clients have attempted to navigate the new normal of an unprecedented situation.[1] In addition to impacts on due diligence, material adverse effects clauses, termination provisions, contingent payment mechanics and representations, warranties and covenants, potential acquirers have also had to…
On December 2, 2020, the Department of Health & Human Services (HHS) published its long-awaited two final rules – one by the Office of Inspector General (OIG) and one by the Center for Medicare & Medicaid Services (CMS) – finalizing changes to regulations implementing the federal anti-kickback statute (AKS), the…
In an effort to lend further support to the expedited development of COVID-19-related vaccines and therapeutics (see Covid-19 Prioritized Examination Pilot Program), the United States Patent and Trademark Office (USPTO) has implemented a deferred-fee provisional patent application pilot program whereby applicants filing under 35 U.S.C. 111(b) can elect to defer…
World affairs are currently clouded by the global COVID-19 pandemic. In a very short period of time, approximately 191 vaccine projects have been launched according to the World Health Organization (WHO). Among the countries with a particularly large number of projects, approximately twenty in total, is Germany. This already displays…
…the essential criterion for being classified as a medical device is the software’s medical objective… Background Relying on an unregulated app or piece of standalone software to provide a diagnosis or recommend treatment could have potentially life-threatening consequences. In June 2020, the UK’s medical devices regulator, the Medicines and Healthcare…
On December 1, 2020, Nasdaq filed a proposal with the SEC to adopt new listing rules relating to board diversity and heighted disclosure. Nasdaq’s position is clear – “diversity in the boardroom is good corporate governance.” Citing the recent social justice movement and a wide range of studies linking board…