ENISA Publishes Threat Landscape Reports for
2020 On October 20, 2020, the European Union Agency for
Cybersecurity ( ENISA ) published a series of reports on the threat
landscape in 2020. The reports focused on, among other things,
malware, data breaches, ransomware attacks, information leakage,
and phishing attacks. The reports identified and evaluated the top
cybersecurity threats for the period of January 2019-April
2020.
ENISA Publishes Guidelines for Securing the IoT Supply
Chain On November 9, 2020, ENISA published guidelines on securing the supply
chain for the IoT. The guidelines address the entire lifespan of
IoT product development by offering security measures for each step
(i.e., requirements and design, end use delivery and maintenance,
The Biological Product Patent Transparency Act (“BPPT”)
1 – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the first-ever provision requiring public listing in the FDA’s “Purple Book” of certain patents associated with biologic drug products (
e.g., monoclonal antibody products and other protein drug products). See the text of the BPPT here.
The BPPT sidestepped some of the more controversial approaches to biologics patent listing, by piggybacking off of the patent lists that reference product sponsors (
i.e., biologics innovators) are already required to exchange with biosimilar applicants
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In follow-up to our colleagues recent post about the newly implemented Medical
Device Regulation ( MDR ) in the European Union, this
post will discuss some of the similarities between FDA s
Clinical Decision Support ( CDS ) Software Draft Guidance (together the CDS Draft
Guidance ) and the MDR.
While still in draft form, we note that FDA has signaled its intent to finalize the CDS
Draft Guidance in 2021.
STATUTORY FRAMEWORK
Under the current CDS Draft Guidance, FDA first bases its
approach to CDS on criteria set forth in the 21st Century Cures Act
Regulatory And Legislative Actions Set The Tone For Biosimilars In 2021
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
The abbreviated biosimilar licensure pathway created by the Biologics Price Competition and Innovation Act (BPCIA) in 2010 was designed to increase competition for biologics and reduce healthcare costs. Already, FDA has licensed almost 30 biosimilars, nearly 20 of which are available to patients in the United States. While 2020 saw a slowdown in FDA approvals and biosimilar product launches from previous years, market uptake of biosimilars increased and more biosimilars are sure to come. FDA has reported numerous biosimilar-related submissions in its pipeline for Fiscal Year (FY) 2020, including seven original biosimilar biologics license application (BLA) submissions in FY 2020. As of FY 2020 Q4, there were 84 biosimilar development programs enrolled in the biosimilar biological product development (BPD) program. In addition, with the B
Currently, eight major food allergens are defined in the FD&C Act. Absent from this list is sesame, which 49% of the U.S. population report having an allergy to. In November 2020, FDA issued a Draft Guidance indicating that sesame should be voluntarily declared on the food label.