Services
Lachman offers a full portfolio of capabilities to deliver measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by the FDA.
Learn More
About Lachman
Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA and industry experts has offered compliance, regulatory affairs, and technical services to clients around the world.
Learn More
Blog
Our blogs feature and report on the latest news and trends in the industry.
View the Blog

Latest Blogs

FDA Webinar on Medical Device Q-Submissions; They Require Both Precision and Timing

On June 11, 2019, the FDA held a CDRH webinar on the Q-Submission Program for Medical Device Submissions.  The webinar was based on the recent May 7, 2019 Final Guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.”  This guidance document supersedes “Requests for Feedback on Medical Device Submissions: Pre-Submission Program and Meetings with FDA and Staff.”

So,

Official Approval, Receipt, and Complete Response Numbers for May and June Slow Out of the Box for ANDA Approvals

The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here),  83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions.  This is the first time this FY that the total has fallen below 100 approval actions in a single month.

Could the Compounding Responsibility Move to CDER’s Office of Compliance Signal Increased Enforcement Priorities?

We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.”  While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a tougher enforcement stance from the Agency.

Update on Discrepancy Provided by FDA Regarding April Approval Numbers

In our post from June 10, 2019 (here), we commented on an apparent revision in the number of approved ANDAs from the month of April (a change from 98 to 93).  While scratching our heads about the apparent discrepancy, the FDA’s Kristofer Baumgartner, M.A., Director, Division of Public Education and Outreach,

About Lachman

Latest News

Frances Zipp of Lachman Consultants to be Featured Speaker at Annual Medicines for Europe Conference

(Westbury, NY – May 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, will be participating as a Conference Sponsor at the 25th annual Medicines for Europe and IGBA Conference. Entitled “Committing to Global Health – Balancing Access and Sustainability,” this year’s event is focused on generic,

Accomplished Global Pharma Executive Mary Oates Joins Lachman Consultants, Inc. as VP of Compliance Services

(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,