Clinical Pharmacology Considerations for Peptide Drug Products, September 2023
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...
Meet the Expert: Shauna Burns
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
Navigating Market Access & Reimbursement Strategy for Medical Products
Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. One critical aspect that often...
A Closer Look at FDA's Nitrosamine Impurity Regulations for NDSRIs
FDA Provides Acceptable Intake Limits for Nitrosamines Drug-Substance Related Impurities (NDSRIs). Can You Comply? The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled;...
EU Pharmaceutical Legislation Reform
On April 26th, 2023, a Commission formed by the European Health Union proposed a groundbreaking revision of the EU’s Pharmaceutical legislation, marking the most significant reform in over two...
Regulatory Sciences
Biotech Startup Approaching IND: 5 Mistakes to Avoid While Writing a Development Plan
In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...
International Recognition Framework (IRF): Are You Ready?
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international recognition framework (IRF) for medicines and devices. The IRF will be in place from January 1st,...
FDA Proposes New, Easy-to-Read Medication Guide for Patients
The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for...
Quality & Compliance
Integrity and Reliability Concerns in Bioequivalence Studies: An Insight into the Synapse Labs Inspection
In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...
Regulatory Sciences
FDA Issues Draft Guidance on Psychedelic Drug Development
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance on the development of psychedelic drugs. There has been a growing interest in using psychedelics for the treatment of...
FDA's Concern over Diethylene Glycol (DEG) and Ethylene Glycol (EG) Contamination
Recent contamination of several drug products in India resulting in fatalities have prompted a new FDA guidance entitled "Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch...
Meet the Expert: Jens van Wijngaarden
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Quality & Compliance
The Importance of Responding to FDA 483 Observations
This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...
Quality & Compliance
FDA Form 483: Common Pitfalls You Can Avoid
This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...
Regulatory Sciences
Who’s Watching? Why You Should Care About Global Promotional Material Review
Recently, there have been two notable cases regarding pharmaceutical advertising code violations based on LinkedIn content. It was announced that Danish drugmaker Novo Nordisk has been suspended by...
EMA’s Regulatory Science Strategy to 2025 is on Track
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...