FDA Featured Articles
-
Is FDA's COVID Container Closure System Guidance Useful Post-Pandemic?
1/9/2024
The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.
-
Navigating The Marketing Authorization Process In Europe
2/6/2018
To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.
-
Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities
9/21/2017
This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
-
Understanding And Delivering Your EU Orphan Drug Launch
8/25/2017
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.
-
Autologous Cell Therapies At Crossroads With FDA: What To Do Now?
7/25/2017
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?
-
What Does "Child Resistant Packaging" Mean In Pharma?
5/26/2017
Child resistant packaging intergrates the use of safety mechanisms and physical barriers to reduce the risk of poisining in children via the ingestion of potentially hazardous medicines.
-
Managing GxP Environmental Systems To Ensure Data Integrity
3/9/2017
In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.
-
Classification And FDA Regulations: Medical Device, Pharma, Combo Products
4/12/2016
How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product.
-
Payer Reaction To FDA Safety Warnings — What Pharma Manufacturers Need To Know
3/16/2016
On October 22, 2015, the FDA released a statement describing updated liver safety warnings for Viekira Pak. Data indicated that Viekira Pak was associated with 26 cases of medication-associated liver injury. Stakes were high in the multibillion dollar hepatitis C (HCV) market, with the fate of one of only two major competing products now unknown. Precision For Value sought to understand the payer reaction by studying payer viewpoints related to a new safety signal in the HCV space.
-
Drug Serialization: Key To Protecting Patients In U.S. And International Markets
2/12/2016
Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise.