Pharma & Life Sciences

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.

WHO Expert Committee on Specifications for Pharmaceutical Preparations 57th Report

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has released its 57th report, recommending new and revised guidance texts for pharmaceutical quality assurance. These include updated GMP for excipients, new GMP for radiopharmaceutical cold kits, revised lab quality control practices, and updated biowaiver guidelines.

DEA Announces 10,744 Arrests in DC Safety Initiative

The Drug Enforcement Administration (DEA) announced 10,744 arrests as part of an initiative to enhance safety in Washington D.C. The operation involved collaboration between local and federal law enforcement agencies, with the goal of removing illicit substances from communities.

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 Drug Shortage Update

The FDA has updated its list of current and resolved drug shortages. The notice indicates 56 drugs are currently in shortage, 45 have been resolved, and 11 have been discontinued. This update provides a snapshot of the ongoing drug supply situation.

FDA Report on Drug Shortage Prevention Efforts

The FDA has released its annual report to Congress detailing efforts in calendar year 2024 to prevent and mitigate drug shortages. The report highlights successful interventions that prevented 283 potential shortages, with only 15 new shortages identified.

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.

DEA Reports 10,712 Arrests and Reduced Drug Availability

The DEA announced 10,712 arrests and a reduction in drug availability on the streets of Washington, D.C. This enforcement action, in coordination with other law enforcement agencies, aims to improve public safety and reduce crime.

DEA Seizes $600,000 from Semi-Truck Driver

The DEA Houston Division announced the seizure of over $600,000 from a semi-truck driver suspected of transporting funds for Mexican cartels. The seizure was a joint effort with the Department of Homeland Security (DHS).

FDA Approves 5 New Novel Drugs in 2026

The FDA has announced the approval of five new novel drugs in 2026 for various medical conditions. These approvals include treatments for achondroplasia, hyperarginemia, schizophrenia, bipolar disorder, atopic dermatitis, and Menkes disease. The agency updated its list of novel drug therapy approvals.