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WHO Expert Committee Adopts New Pharmaceutical Guidance

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has adopted nine new guidance texts aimed at ensuring the quality assurance of medicines. These texts cover areas such as nitrosamine prevention, good manufacturing practices for excipients, and bioequivalence assessments, and are recommended for implementation.

EMA PRAC Warns of Aseptic Meningitis Risk with Ixchiq Vaccine

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the product information for the chikungunya vaccine Ixchiq to reflect recent evidence of aseptic meningitis risk, particularly in healthy young adults. This follows a safety signal investigation and is part of a regular safety assessment.

FDA Extends Drug Use Dates Due to Shortages

The FDA has extended the use dates for specific lots of certain drugs to help alleviate drug shortages. This guidance allows providers and patients to use these lots beyond their labeled expiration dates, based on manufacturer stability data. The agency is not requiring relabeling but expects replacement and disposal when new product becomes available.

FDA Novel Drug Approvals 2025

The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.

FinCEN Whistleblower Program Bulletin on Fraud-Related AML and Sanctions Violations

FinCEN has issued a bulletin highlighting its whistleblower program, encouraging tips on violations of the Bank Secrecy Act (BSA) and sanctions programs, particularly those involving fraud. The bulletin details types of fraud schemes and reporting expectations for financial institutions.

Central Counterparty Management of Liquid and Prefunded Resources

The Office of Financial Research published a working paper analyzing central counterparty (CCP) resource demands. The paper presents a framework for understanding aggregate CCP resource demands, integrating various dimensions of CCP heterogeneity and empirical data. It offers reflections on CCP liquidity management, particularly concerning physically settled contracts and the implications of insufficient liquid resources.

Working Paper on Client Clearing, Netting Efficiency, and Pricing

The Office of Financial Research published a working paper analyzing client clearing services in centrally cleared markets. The paper, based on confidential data, demonstrates how client clearing improves netting efficiency for dealers and offers pricing advantages to clients, enhancing market access and competition.

OCC Enforcement Action Types

The Office of the Comptroller of the Currency (OCC) has published a guide detailing the types of formal enforcement actions it can take against supervised financial institutions and their affiliated parties. The document outlines various actions including Capital Directives, Cease & Desist Orders, and Civil Money Penalties.

NCUA Extends 18% Loan Interest Rate Ceiling for Federal Credit Unions

The National Credit Union Administration (NCUA) has extended the temporary 18% interest rate ceiling for loans made by federal credit unions. This extension, approved by the NCUA Board, will now last through September 10, 2027, providing continued flexibility for consumer lending.

NCUA Removes Reputation Risk from Banking Guidance

The National Credit Union Administration (NCUA) has removed reputation risk from its examination and supervisory guidance, effective September 25, 2025, in accordance with Executive Order 14331. This change directs NCUA employees to no longer base supervisory concerns on reputation risk when examining federally insured credit unions.