Why It's Smarter to Play the Long Game When Planning Your FDA Submission
The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your...
How to Ensure Your Device, Software, and Drug Are All Ready for a Pre-Approval Inspection
When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...
505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway
Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug...
What You Need to Know About the ICH
The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices....
FDA Announces Plans to Resume Domestic Inspections with New Risk Assessment System
On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency's plans to resume "prioritized domestic inspections of FDA-regulated...
Improving Cost Efficiency, Speed, and Completeness of Generic Applications
An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once...
How Should You Respond & React When Employees Become Infected with COVID-19?
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
How Opioid Analgesic Drugs are Approved by the FDA
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
3 Factors to Consider in the Manufacturing Phase for Drug Device Combination Products
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...
Regulatory Sciences
Pediatric Labeling Best Practices
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic
Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...
FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
FDA Works to Accelerate the Development of COVID-19 Treatments with New Guidance Documents
On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to...
FDA Emergency Use Authorizations 101: COVID-19 Medical Devices
Everything You Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from...
Now May be the Time to Approach the FDA Regarding CMC and Nonclinical Questions – Giving These Topics the Attention they Deserve
Due to the current regulatory landscape that has been created by the COVID-19 pandemic, clinical trials have been disrupted across the globe. To many Sponsors, this may feel like a loss of progress...
COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials
As of March 27, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations...