FDA Streamlines Biosimilar Development Guidance

The FDA issued draft guidance to streamline biosimilar development by recommending the reduction of unnecessary clinical pharmacokinetic testing when scientifically justified. This initiative aims to save developers up to 50% in PK study costs, potentially lowering drug prices and increasing patient access to affordable biologic treatments.

FDA Approves Wellcovorin for Cerebral Folate Deficiency

The FDA has approved Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed FOLR1 gene variant. This marks the first FDA-approved treatment for this rare genetic condition.

FDA Launches Unified Adverse Event Analysis Platform AEMS

The FDA has launched a new unified platform, the Adverse Event Monitoring System (AEMS), to analyze adverse event reports for all regulated products. This modernization aims to improve data accessibility, transparency, and surveillance capabilities, replacing fragmented legacy systems and is expected to save $120 million over five years.

ERISA, HIPAA, COBRA Technical Releases

The Department of Labor's Employee Benefits Security Administration (EBSA) has compiled a list of technical releases related to ERISA, HIPAA, and COBRA. These releases provide guidance on various aspects of employee benefit plans, including health insurance, claims, and disclosures.

CFPB Final Rule: 2026 Maximum Charge for FCRA Disclosures

The Consumer Financial Protection Bureau (CFPB) issued a final rule establishing the maximum allowable charge for Fair Credit Reporting Act (FCRA) disclosures for the 2026 calendar year. This annual adjustment is required by the FCRA.

Consumer Leasing Regulation M Final Rule - Threshold Update

The Consumer Financial Protection Bureau (CFPB) has finalized amendments to Regulation M, increasing the dollar threshold for exempt consumer leases from $71,900 to $73,400, effective January 1, 2026. This adjustment is mandated annually based on the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W).

Truth in Lending Regulation Z Threshold Increase

The Consumer Financial Protection Bureau (CFPB) has finalized an amendment to Regulation Z, increasing the dollar threshold for exempt consumer credit transactions. Effective January 1, 2026, the threshold will rise from $71,900 to $73,400, adjusted annually based on the Consumer Price Index.

HPML Appraisal Exemption Threshold Increased to $34,200

The CFPB, OCC, and Federal Reserve have finalized amendments to the Truth in Lending Act (TILA) regulations, increasing the exemption threshold for higher-priced mortgage loan (HPML) appraisals. Effective January 1, 2026, the threshold will rise from $33,500 to $34,200, adjusted annually based on the CPI-W.

CFPB Rescinds Adjudication Rule Amendments

The Consumer Financial Protection Bureau (CFPB) has rescinded amendments made in 2022 and 2023 to its Rules of Practice for Adjudication Proceedings. This action reverses changes related to depositions, timing, bifurcation, dispositive motions, and issue exhaustion, with some narrow exceptions for clarificatory changes.

CFPB Guidance on Commenting on Bureau Notices and Regulations

The Consumer Financial Protection Bureau (CFPB) has updated its guidance on how the public can submit comments on Bureau notices and regulations. The document clarifies procedures for submitting comments, what types of comments are generally posted publicly, and what information should be excluded.