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Quality & Compliance
We saw in Part 1 of this series how a confidence interval can be calculated to define a range within which the true value of a statistical parameter such as a mean or standard deviation is likely to...
In a Federal Register notice published today, the Food and Drug Administration (FDA) announced its intention to take enforcement action against misbranded or unapproved prescription products...
Quality & Compliance
If enforcement against pharmaceutical companies for off-label promotion by the Office of Inspector General (OIG) and the Department of Justice (DOJ) and the Food & Drug Administration (FDA) were not...
Regulatory Sciences
The Food and Drug Administration (FDA) recently published a draft guidance that outlines the “Naming of Drug Products Containing Salt Drug Substances” in accordance with the recently implemented USP...
Quality & Compliance
If you have been following along, you now know that I have reviewed the first three gates to the Nine Gate Transfer Process for moving production from site to site. I have covered: Gate 1: Assessment...
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...
The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...
Regulatory Sciences
In a Federal Register notice to be published on Dec. 10, 2013, FDA announced the release of a new guidance titled “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules.” The...
Full-Service CRO
Today I would like to present the third entry in the series discussing the Nine Gate Transfer Process for moving production from site to site: the Gate 3 Transfer Plan. In case you missed them, you...
A wise man recently told me that “honor and respect should be given freely, but trust is earned”. Whether it’s in politics, friendships, church, marriages, parenting or even the business world,...
Full-Service CRO
In this, the second entry in the series, I will review Gate 2 of the Nine Gate Transfer Process utilized by ProPharma Group for successful technical transfers. Refer to my first entry for further...
Regulatory Sciences
On Nov. 13, 2013, the Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register. The title of the Proposed Rule is “Supplemental Applications Proposing Labeling Changes for...
Quality & Compliance
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
Full-Service CRO
Pharmaceutical news today featured another article about a manufacturing plant closure and the layoff of a thousand employees. Demand for pharmaceutical products continues to grow and will continue...
Quality & Compliance
Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA...
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...
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...
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 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...
The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and...