The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agencys pre- and postmarket decisions for marketing applications. Read more about FDAs draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.
The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?
The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.
The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain
The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.
Change control is mandatory to maintain the validated state also for computerised systems and is subject to inspections. What are the regulatory requirements and what is the inspection practice?
The United States Food and Drug Administration (FDA) has recently published a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. The letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.
Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, an evaluation of the last two fiscal years shows that deficiencies in the stability program are mentioned in numerous FDA 483s.
Thermal sanitization is still the most common method for keeping pharmaceutical water plants under microbiological control. Some systems are stored at high temperatures - but often water systems are heated up cyclically to an elevated, germicidal temperature. Here, the question of optimal temperature often arises.
The FDA has published a draft Guidance for Industry with the title "Selected Update for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices". What will come?