A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

FDA Interactions with Industry Under Scrutiny

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

Crossing the Same River Multiple Times

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

Controlling Quality in Aging Facilities

Topic

Grant Playter is the Assistant Editor for 

Articles

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation. 

First Drugs Hit by Inflation Reduction Act Price Controls

Mike Wilson, QA/QC Strategy, Waters Corporation

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

Mitigating Human Error and Supporting Compliance with Smart Technology

Paul Van Tilborg is director of analytical sciences at Ardena.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Phase-appropriate Analytical Methodology

Amanda Guiraldelli is scientific affairs manager at the United States Pharmacopeia.

Jane Weitzel is an independent consultant and chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.


Evolution of Analytical Procedure Validation Concepts: Part II

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.


Evolution of Analytical Procedure Validation Concepts: Part I

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability. 

FDA Seeks $7.2 Billion to Protect and Advance Public Health

 Washington Editor, jillwechsler7@gmail.com.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Congress Probes PBM Link to Higher Drug Prices

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% 

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Quality/GMPs

FDA Interactions with Industry Under Scrutiny

Crossing the Same River Multiple Times

Controlling Quality in Aging Facilities