Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.
Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.
The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.
The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.
The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.
Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration's (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector.
As a part of the effort, IPC created a short film on PvPI, a pharmacovigilance comic published in multiple vernacular languages to enhance public awareness, and a new online reporting platform designed for easy access through a QR code.
The US Food and Drug Administration (FDA) on Tuesday published a warning letter to Indian drugmaker Hikal Limited for supplier evaluation and its handling of complaint investigations. The agency also warned an oncologist for failing to follow clinical trial enrollment protocols and for failing to obtain informed consent from a trial participant.
Malaysia's Medical Device Authority (MDA) and Singapore's Health Sciences Authority (HSA) unveiled a pilot program that could accelerate access to Class B, C, and D medical devices. The pilot program begins on 1 September and runs through 28 February.
The US Food and Drug Administration (FDA) is seeking public input on its PreCheck program, which aims to establish new pharmaceutical manufacturing facilities in the US to enhance the pharmaceutical supply chain.
On 13 August, President Donald Trump issued an executive order directing the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) to identify 26 drugs that are essential for public health. The executive order also mandates that a six-month supply of active pharmaceutical ingredients (APIs) necessary for manufacturing these drugs be stockpiled. ASPR has 30 days to compile this list of essential drugs.
The US Food and Drug Administration (FDA) has cited several manufacturers for failing to conform to current good manufacturing practices (CGMP) and quality system regulation (QSR) requirements. The agency also warned several online retailers for illegally marketing Schedule II stimulants, opioids, and benzodiazepines.
