Industry News
Inspection of Biotechnological Manufacturers: PIC/S AiM Updated
In January 2021, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire. The aide memoires were drafted with the aim of facilitating the effective planning and conduct of GMP...
Updated Guidance on the Management of Clinical Trials during COVID-19
The European Medicines Agency (EMA), the Heads of Medicines Agency (HMA) and the European Commission (EC) have published a joint guidance on the management of clinical trials during the coronavirus pandemic. The guidance has been revised in February (Version 4) to...
Conduct of Clinical Trials During COVID-19: Guidance for Industry, Investigators, and Institutional Review Boards
FDA has provided general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. This...
World Health Organization: Guidance on COVID-19 Vaccine Allocation
The Strategic Advisory Group of Experts on Immunization (SAGE) of the World Health Organization (WHO) has released two key documents to help guide the allocation and prioritization of populations to receive COVID-19 vaccines. As safe and effective vaccines for...
FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
On October 15, 2020, U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s...
Draft Guidance from FDA: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
New guidance from FDA reflects current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. Cannabis and cannabis-derived compounds that may be used in drug manufacturing...
Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and...
Data Integrity for Pharmaceutical Grade Excipients
On April 30, 2020, the International Pharmaceutical Excipients Council (IPEC) Federation published a position paper on the relevance of data integrity guidance documents to the manufacture and supply of excipients. "Although data integrity is clearly relevant to...
MWA Welcomes Sumaiya Reza as Vice President of Client Services
MWA is pleased to announce that Sumaiya Reza has joined our team as Vice President of Client Services. Sumaiya will lead business development and account management activities at MWA, with the primary goal of providing our clients with superior consulting services...
Data Integrity for Pharmaceutical Grade Excipients
In April 2020, IPEC released a position paper describing its position on the relevance of data integrity guidance documents to the manufacture and supply of excipients. "Maintaining data integrity is fundamental to the application of GMP. Published regulatory guidance...