The Lachman Blog

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22
Mar
Clear Vision early fall in rocky mountains

Transparency for Decision-Making Process Coming to an Inspection Near You!

In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”  This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA). The anticipated outcomes of […]

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21
Mar
The word Hope written on a multi-colored background

AAM Testifies at Opioid Hearing

Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ). The testimony addresses the following major points. It is critical that we combat the […]

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14
Mar
Business Woman Busy Phone Wait Five Minutes Gesture Palm Free space Concept

OGD First-Time ANDA Approvals for 2018 and What They May or Not Mean to Consumers

Even though the slowdown in ANDA approvals, attributable to the issues of elemental impurities, has dampened the first two month of 2018 (here),  the number of first-time generic ANDA approvals seems to be higher than would be expected.  FDA reported 10 first-time generics (note that there may be multiple reports for the same drug if […]

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13
Mar

Constance Richard-Math, new Director at Lachman Consultant Services, Inc.

We are pleased to announce that Constance Richard-Math has accepted the position of Director in the Compliance Practice at Lachman Consultants. Constance Richard-Math joined Lachman Consultants after a 20-year career at the U.S. Food and Drug Administration where she rose to the position of Director, Investigations Branch at the Baltimore, Maryland District Office. While at […]

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05
Mar
A young family sits talking to the doctor. The toddler is sat on his mother’s knee as the doctor kneels

US FDA Guidance – Good Clinical Practice: Integrated Addendum to ICH E6(R1)

The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here).  The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States. The guidance clearly identifies the added revisions, […]

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