March 2016

29
Mar

Promoting and Protecting Data Integrity

The integrity of data used to ensure the quality of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. The topic of “Protecting and Promoting Data Integrity” was presented by Kathleen Culver from FDA (Field Investigator and Drug Preapproval Manager, FDA Cincinnati District), Tracy Moore (Senior GMDP Inspector and GMDP Operations Manager, MHRA), and Paul Vogel (Chairman, Lachman Consultant Services, Inc.) at the recent PharmaLink Conference, which was co-sponsored by Xavier Health and the FDA, held on March 16-17, 2016 in Cincinnati, Ohio.

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28
Mar
COMPLETE RESPONSE LETTERS DUE TO FAILED PAIS – MORE TO COME Image

Developments in Continuing Process Verification

The key to developing a practical approach to all phases lies in the establishment of Critical Quality Attributes (CQA) for the drug product and assignment and monitoring of Critical Process Parameters (CPP) that have a direct effect on the performance of the process with regard to the CQA. At the PDA Annual Meeting last week, Scott Bazzone, Senior Manager of Quality Assurance Validation at Pfizer presented the approach that is used there with regards to establishing the risk significance or Z Score of a CPP to the CQA.

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25
Mar

Generics Draft Abuse-Deterrent Guidance Issues

The questions about what and how a generic abuse-deterrent product has become somewhat more clear with the issuance today of the Draft Guidance for Industry – General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The Guidance document describes the types of tests (comparative in vitro studies and, in some cases, relevant pharmacokinetic or other studies that may be appropriate) that a generic applicant should undertake when seeking approval for a Reference Listed Drug (RLD) opioid product that has abuse-deterrent properties described in its labeling.

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22
Mar

LCS Exhibits at PDA Annual Meeting

From March 14-15, LCS hosted a booth at the PDA Annual Meeting in San Antonio, Texas. The meeting was attended by over 850 pharmaceutical professionals, representing both industry and regulators.  Linda Evans O’Connor, Director, and Michele Sinoway, Senior Manager, met with many potential clients and FDA representatives, and are sure this will be a very […]

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22
Mar

Who Are These Guys?  OGD Updates Part of Its Organizational Chart

The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.

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21
Mar

Fran Zipp and Terri Nataline Present at DCAT Week

On Tuesday, March 15, 2016, our President and CEO Fran Zipp and Senior Associate Terri Nataline presented in a forum entitled “GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes” at DCAT Week. DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and […]

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20
Mar

Complete Response Letters Reach 3rd Highest Monthly Total Under GDUFA

February saw the 3rd largest number of Complete Response Letters (CRLS) issued (129) in a single month since the implementation of GDUFA. Previous highs were 134 in July FY 2015 and 130 reached in November FY 2013. With the review machine gearing up, wouldn’t one expect the number of CRLs to be steadily increasing each month? Maybe not! If the information requests (IRs) keep flying out the door along with easily correctable deficiencies (ECDs), then maybe the number of CRLs will remain lower. Or is that wishful thinking? That logic would seem to mean that the number of approvals should be soaring. Well, if you look at the total number of approval actions plus the number of CRLs, the total has actually been going up, and why? Because the number of monthly approvals has increased in FY 2016!

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14
Mar

Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet?

The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Response Letters (CRLs) rather than clear movement towards application approval. Well, some three years into GDUFA I, there now seems to be a better understanding of what industry thought they got and FDA has adopted, albeit outside of the direct language in the Goals Letter, policies that are driving application towards approval.

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