Industry News
Draft Guidance from FDA: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry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...
Remote Release and Remote Audits: New Answers from the EU
From ECA Academy The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing...
Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
FDA has temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated...
FDA Emergency Use Authorization for in vitro diagnostics (COVID-19)
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19....
Newly Revised ISO Standard Will Help Device Manufacturers Address Risk Management
(from RAPS, December 2019) The International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and...
Audit Trail Reviews of Electronic Health Records
Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections. Issues have been noted with audit trails, access and security, scanning and certified...