Pharmacovigilance
Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...
Quality & Compliance
Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes...
Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...
Regulatory Sciences
One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...
Regulatory Sciences
Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...
Regulatory Sciences
Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...
Regulatory Sciences
The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...
Regulatory Sciences
What is the Animal Rule? The Animal Rule, a regulation set by the US Food and Drug Administration (FDA), applies to the development and testing of drugs and biological products intended to reduce or...
Regulatory Sciences
This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...
This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...
The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the...
The year 2023 unveiled an eventful chapter in FDA drug approvals, heralding a resurgence of innovation after a brief decline. This period represented not just a numerical rebound but a meaningful...
The FDA has recently published a number of software related guidance documents, covering topics such as off-the-shelf software, cybersecurity, closed-loop-control, and predetermined change control...
As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...