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Regulatory Sciences
With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...
Quality & Compliance
When a biopharmaceutical company builds new or renovates existing manufacturing space, the last consideration before turning the production key is the environmental monitoring of the same. This short...
Regulatory Sciences
On September 23, FDA released a report regarding “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This fulfills FDA’s PDUFA commitment to issue a report of findings...
Quality & Compliance
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...
Regulatory Sciences
Medical device manufacturers may need to re-think their approach to demonstrating substantial equivalence (SE) in the 510(k) notification process, due to the FDA’s recent finalization of the guidance...
Quality & Compliance
From time to time in this industry, you will hear someone bemoaning the fact that they have to do a cleaning validation. If this happens to be you, have no fear and remember the following five points...
Quality & Compliance
In our previous blog, "The Difference between Quality and Compliance", I mentioned that there are recent initiatives underfoot that FDA hopes will create FDA-industry partnerships, increase...
Quality & Compliance
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Quality & Compliance
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their...
Quality & Compliance
So far in our series on GAMP 5 we’ve provided a high level overview of the five major GAMP concepts, and a more in depth discussion of Concept 1, Process Knowledge and Understanding. In this...
Quality & Compliance
Today, more pharmaceutical companies are turning to outsourcing their products as a strategic part of their business model. There are a number of drivers for this shift to soliciting the services of...
When it comes to the Healthcare industry (e.g. pharmaceuticals, medical devices, dietary supplements, etc.) who owns a company's Quality Assurance practices? Without a doubt the Quality organization...
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...