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Quality & Compliance
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Quality & Compliance
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
Regulatory Sciences
On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...
Quality & Compliance
The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has...
Regulatory Sciences
In 2013, the FDA released a guidance entitled "Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements." This guidance was finalized after...
Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process: The Parenteral Drug Association (PDA) recently published a revised version of Technical Report No....
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
Full-Service CRO
On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled "Pediatric Study Plans: Content of and Process for Submitting...
Quality & Compliance
The 21st Century Cures Act, (Passed December 13, 2016), represents three years of cooperation between Congress, the FDA, and industry to modernize the current legal framework within which the FDA...
Quality & Compliance
The recent passage of the 21st Century Cures Act (passed December 13, 2016) marks a significant milestone for medical device and drug development. I recently attended a meeting held by the Food and...
On September 7, 2005, FDA announced the availability of a draft guidance, entitled "How to Comply with the Pediatric Research Equity Act," providing sponsors with a number of recommendations...
On November 3rd and 4th, I had the opportunity to meet with Pharmaceutical industry experts at the PDA Outsourcing / CMO conference in Washington, DC. It was a fantastic event with representatives...
Quality & Compliance
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...
Full-Service CRO
For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list....
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...