Author Archive

GDUFA’s Effect on Drug Master Files

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) was passed by the US Congress. The Act, to be implemented from Oct. 1, 2012, is designed to streamline the generic-drug review process and has been welcomed by the pharmaceutical industry. However, there have been a lot of unanswered questions regarding the general outcome of GDUFA and how it will impact the industry.

The GDUFA agreement includes application fees for original Abbreviated New Drug Applications (ANDAs), prior approval supplements (PAS), and Type II Drug Master Files (DMFs) for APIs. Based on the fee structure, Type II DMFs will account for 6% and the API manufacturing facilities will account for about 14% of the GDUFA fees, respectively. To fulfill the GDUFA requirements and to streamline the DMF review process, the FDA Office of Generic Drugs (OGD) has established a DMF Review Team, with a future possibility of a division, which will be dedicated to review of API information submitted in Type II DMFs. With all the changes in the Type II DMF review processes that are covered in the GDUFA legislation and given the fact that there is currently a lack of adequate information available to the industry, there have been many industry questions and speculations regarding the impact of GDUFA on the submission and review of Type II DMFs.

In the September 2012 issue of PharmTech, former OGD reviewer Dr. Aloka Srinivasan, now with Parexel, answers some of these common questions.

MIT Survey Aims to Correlate Product Lifecycle and Manufacturing Site Characteristics with Product Deviations

In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites. The comprehensive survey on topics related to site characteristics, quality approaches, quality activities, perception of relative consistency of regulators, product-level process details, and product-level compliance performance was deployed over the past 18 months as a secure web-based questionnaire directly to biopharmaceutical manufacturing sites through several different channels. The individuals targeted for inclusion as survey respondents have been manufacturing plant managers or their representatives.

Read the interim results and if you haven’t yet, the survey can be taken on behalf of a biomanufacturing site usin this link.

PhRMA Awards Ceremony Inspiring for Alzheimer’s Workers, Researchers

Angie DrakulichEarlier this week, on Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) honored nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The event was at the Washington, DC, Newseum and featured as keynote speakers Marc Kennedy Shriver, who wrote a book about his father’s experience with Alzheimer’s, and Meryl Comer, an Emmy award-winning journalist.

The evening was about inspiration and motivation to keep up the fight against AD, whether as caregivers, patient advocates, health professionals, or scientists. Read more »

LIVE from PDA FDA Joint Regulatory Conference 2012

Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore, at Twitter@PharmTechAngie or Twitter@PharmTechGroup. Today’s sessions focused on common regulatory citations (the word is that they haven’t changed much in the past 10 years), new ways to handle internal investigations from Big Pharma organizations such as Amgen and Abbott (including a bit of an audience stirup surrounding the management, or lack thereof, of Class I investigations), FDA encouragement of sending novel excipients in for review, best practices for selecting excipients for new drugs (including how to best deal with suppliers), updates on ICH Q11, and a lot of information on knowledge management, risk-based approaches (including QbD), and lifecycle approaches. More information to come tomorrow when the various FDA offices give their reports.

PhRMA’s Research and Hope Awards Unveiled

Angie DrakulichOn Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) will honor nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The statistics surrounding AD have been plaguing families for decades. The disease is the sixth leading cause of death in the US today, according to the Alzheimer’s Association, with 5.4 million people currently affected. By the year 2050, one American will develop AD every 33 seconds.

The costs surrounding AD, from both a financial and time perspective, are also disheartening. The Alzheimer’s Association notes that the US spends an estimated $200 billion on AD per year, and families across America and around the globe are all too aware of the intense care and attention that AD patients require. These are just some of the reasons why PhRMA has focused on AD for its award program, which launches this year, replacing the PhRMA Discover’s award program. Read more »

IMS Predictions Foretell Change, Positive Change

Angie DrakulichIMS Health released its latest global spending report over the summer, confirming that times for the pharma market are indeed changing. The dreaded “patent cliff” that has likely been haunting the dreams of pharma business leaders for the past few years may still exist, but there is more to look forward to. Estimates from IMS Health seem to demonstrate that the industry has not only been planning ahead to ensure that the plague of patent expiries doesn’t kill business altogether, but has done quite a good job at having a backup plan. Take a look: Read more »

Pharmaceutical-Based Cargo Security and Theft Prevention

Cargo theft, for many years, was a problem that largely plagued the electronics industry, but criminals have recently shifted more attention to the far more lucrative pharmaceutical trade. In March 2010, thieves masterminded a heist of $75 million worth of cancer, psychiatric and blood-thinning drugs from a Connecticut warehouse by cutting a hole in the ceiling and dismantling alarms during a severe storm that masked their activities from the local authorities. To curb future cargo theft, it is imperative that pharmaceutical companies develop solid, globally applicable conveyance security programs.

Read about theft-preventing strategies in the August issue of PharmTech

How to Prepare a Deviation Investigation Report

Deviations happen. FDA recognizes this and requires deviations to be investigated and documented, say Peter Smith and David Elder. The former senior FDA officials are both in strategic compliance consulting at Parexel. When performing a deviation investigation, FDA expects certain things.

For starters, the investigation report must be designed for the reader, providing information and evidence that fully support the findings, conclusions, and actions. The report should relate a story that can be clearly understood by a third party months or even years after the event and the investigation. Read more advice from Smith and Elder in the May issue of PharmTech.

Change Management: How to Deal

Finding an effective and fully compliant change management system that works is not easy. And yet, regulators look for one. Here are a few tips from Peter Smith, in Strategic Compliance Consulting at PAREXEL International, on how to deal with common change management problems such as assessments and documentation of the change. Smith is a former senior official with FDA.

For starters, do not use “planned deviations.” Many companies use the erroneous concept of “planned deviations,” which are not deviations at all, but rather, changes. These changes are often temporary and handled within the deviation management system or similar program. Deviations are unexpected events wherein some control is lost and the product quality impact of the event must be evaluated retrospectively. No one wants to “plan to deviate” and deviations raise a red flag to regulators…. Read the rest of the answer in the June issue of PharmTech.

PhRMA Research Awards Focus on Alzheimer’s Disease

Angie Drakulich

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the United States.  The new annual awards, called the Research and Hope Awards, are replacing PhRMA’s Discover’s Award, and this year, will focus on the fight against Alzheimer’s Disease. The Alzheimer’s Foundation of America, the National Alliance for Caregiving, and the National Association for Home Care & Hospice are cohosting the 2012 event. Read more »

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