As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
7/2/2024
/ Biologics ,
Clinical Trials ,
Congressional Committees ,
Diversity ,
Draft Guidance ,
EU ,
European Commission ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Patient Privacy Rights ,
Pediatrics ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Proposed Legislation
On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more
In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...more
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more
5/21/2024
/ CLIA ,
Clinical Laboratories ,
Compliance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Prescription Drugs ,
Regulatory Requirements
On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biden Administration ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Clinical Trials ,
Cybersecurity ,
Drug Pricing ,
EU ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
NIST ,
Pharmaceutical Industry ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Reform ,
Research and Development ,
Sensitive Personal Information ,
UK
On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
1/4/2024
/ Advertising ,
Biosimilars ,
Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Compliance ,
Draft Guidance ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicare ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Standards ,
Research and Development ,
UK
On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more
On October 30, 2023, President Biden issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO establishes sweeping directives and priorities for federal...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Civil Rights Act ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Procurement Systems ,
Intellectual Property Protection ,
Legislative Agendas ,
National Security ,
NIST ,
Popular ,
Proposed Legislation ,
Public Agencies ,
Regulatory Agenda ,
Semiconductors ,
Technology Sector
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs.
If finalized as proposed, FDA would implement a new...more
On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
10/2/2023
/ Biologics ,
Clinical Trials ,
Compliance ,
Diagnostic Tests ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Public Consultations ,
Regulatory Oversight ,
Regulatory Requirements ,
UK
On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs). If enacted, the proposed...more
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA...more
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and...more
Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
6/30/2023
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Marketing ,
Marketing Authorization Application ,
Med Tech ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for...more
5/26/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Information Blocking Rules ,
Intellectual Property Protection ,
Med Tech ,
Medical Devices ,
Patent-Eligible Subject Matter ,
Popular ,
Safe Harbors ,
Software
The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
5/2/2023
/ Artificial Intelligence ,
Comment Period ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Manufacturers ,
Marketing Authorization Application ,
Medical Devices ,
Pre-Market Notification ,
Software
In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical...more
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase...more
On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the...more