December 2019

05
Dec
Backlog Photo

How Much Does the Clear Out of the Backlog Really Impact Approvals?

Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks.  Granted, the backlog of old applications did […]

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04
Dec
Novel Photo

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency […]

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03
Dec

John Darby, new Senior Director in the Compliance practice at Lachman Consultant Services, Inc.

We are pleased to announce that John Darby has accepted the position of Senior Director at Lachman Consultants, effective December 2, 2019. Mr. Darby is a goal directed, results-focused executive professional with a strong, global background in quality assurance, compliance, audits, training, and remediation. His 18 years of experience and keen insight contribute to his […]

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