Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
On March 30, 2026, the Food and Drug Administration (FDA) published a final guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The guidance provides updated...more
FDA's approach to regulating weight-loss devices has evolved for more than a decade. In final guidance published in March 2026, FDA brings together clinical and non-clinical recommendations in a single document, retains the...more
On February 5, 2026, the U.S. Food and Drug Administration (FDA) issued a letter to food manufacturers announcing a new enforcement discretion policy regarding voluntary “no artificial colors” labeling claims for foods...more
On January 22, 2026, the EEOC decided in a 2-1 decision to rescind its comprehensive “Enforcement Guidance on Harassment in the Workplace.” This guidance was published by the EEOC on April 29, 2024, representing the EEOC’s...more
The UK Joint Money Laundering Steering Group (JMLSG) has published final amendments to Part I of its anti-money laundering and counter-terrorist financing (AML/CFT) guidance for the financial services sector. This follows the...more
2026 got off to a roaring start on the employment law front. After the Employment Rights Act (finally) received Royal Assent just before Christmas, we've got more detail about which rights take effect when. A new right to...more
The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical decision support ("CDS") software, reflecting a pro-innovation and risk-based regulatory...more
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general wellness products (General Wellness Guidance) and clinical decision support software (CDS Software...more
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance)....more
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness Policy for Low Risk Devices...more
Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The guidance outlines the FDA’s current thinking...more
The European Supervisory Authorities (ESAs, comprising the European Banking Authority, European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority) has published a final report...more
The EBA published its final report on Guidelines amending Guidelines EBA/GL/2022/04 on the equivalence of confidentiality and professional secrecy regimes in third countries, reinforcing the EU’s commitment to safeguarding...more
Since 2019, companies that offer software and/or hardware devices aimed at promoting consumer health and wellness have had little more to rely on than a single short U.S. Food and Drug Administration (FDA) guidance document...more
Key Takeaways: FDA updated two key digital health guidance documents to align with the Administration’s emphasis on deregulation and innovation in health care technology, including the use of generative AI....more
The UK Financial Conduct Authority has published a policy statement PS25/23 setting out its final guidance on tackling non-financial misconduct (NFM) in financial services. The FCA is amending the Code of Conduct (COCON) and...more
On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to comply with the Food and...more
The European Securities Markets Authority (ESMA) has published a final report with guidelines on internal controls applicable to benchmark administrators (BMAs), credit rating agencies (CRA) and market transparency...more
Picture this: your next amazing blog post is locked and ready for publication – and you’re ahead of schedule thanks to time saved through use of AI. You know you should be ‘transparent’ about that use, but how do you actually...more
Digit health technologies (DHT) are a key aspect of U.S. Health & Human Services (HHS) Secretary Robert F. Kennedy Jr.’s Make America Healthy Again (MAHA) agenda. DHTs are health care focused technology systems using...more
The Bank of England and the UK Financial Conduct Authority (FCA) have published additional finalised Q&As on derivative reporting requirements under the UK European Market Infrastructure Regulation (UK EMIR) following a...more
The UK Competition and Markets Authority (CMA) has finalised changes to its leniency regime following a public consultation earlier this year. Revised guidance, effective from 28 October 2025, aims to update and streamline...more
The European Securities and Markets Authority (ESMA) has published its final report setting out supervisory expectations for the governance arrangements of entities under its direct supervision. These include credit rating...more
On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the third guidance in a...more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more