The Lachman Blog

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11
Apr

Do the FDA Commissioner’s Remarks Spell Trouble for Generic Opioids?

In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them.  He emphasized that there needs to be a multipronged […]

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04
Apr

TEA Anyone?

The FDA has published a proposed rule regarding Time and Extent Applications (TEAs) that will establish timelines and metrics associated with their review.  Just to remind you, a TEA is now the preferred option to add a product to an over-the-counter (OTC) monograph for products that were initially marketed in the United States after the […]

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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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