FDA Featured Articles

1. Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies 2/8/2018

   In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

2. 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.

3. 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.

4. 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.

5. 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?

6. 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.

7. Incorporate Data Integrity Into Your Pharma Quality Management System 3/28/2017

   A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable. 

8. 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.

9. Perfect Potent API Processing: Handling Hazardous Drug Actives Effectively 10/25/2016

   The journey from discovery to pharmacy is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage.

10. A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017 8/17/2016

    The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.