David G. Lonza, B.S. Engineering, new Head of EU at Lachman Consultant Services, Inc.

We are pleased to announce that David Lonza has accepted the position of Head of EU at Lachman Consultants, effective September 1, 2017.

David Lonza joined Lachman Consultants in August 2016, in the role of Deputy Advisor to the President / CEO – Strategic Initiatives. David’s expertise includes servicing pharmaceutical / biopharmaceutical / biotech clients to meet International Regulatory challenges and Operational Readiness.

New Report, Same Problem? I Am So Confused!

Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month.  In addition, the FDA Approved Drug Products daily listing (here) can now be run for a 7- or 14-day period. 

ANDA Supplements Spike in April

The Office of Generic Drugs (ODG) saw the largest number of changes being effected (CBE) supplements (618) as well the largest number of prior approval supplements (PAS) (57) so far, this fiscal year. While these numbers did not break any previous records (678 CBEs in September 2016 and 71 PAS in August 2016) they certainly show a spike from past months in FY 2017.

OGD Approvals Look About the Same

According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report of the Generic Drug Program in a few days.

Breaking the ANDA Bank – December Submissions Off the Chart

In a previous blog, we postulated that the start of FY 2017 looked like the ANDA submission rate could be off to the races.  We also speculated that December original new submissions might reflect firms’ end of year push to get applications into the Agency.  We did not think we would see a submission number as high as the 235 reported by OGD for December 2016. 

Perhaps Thinking of Someone’s Similar Name? New MaPP May help Avoid Disappointment

Often times proposed proprietary names go down to the approval wire, and sometimes there is last minute disappointment on behalf of at least one of the sponsors.  For instance, when a proprietary name is cleared during the IND, NDA, or ANDA review, in the period between clearance and approval, there may be another applicant that gets approved with a look-alike or similar name that may,

LCS to Exhibit at the ISPE/FDA/PQRI Quality Manufacturing Conference

On June 6-8 at the Bethesda North Marriott Hotel, ISPE will be hosting the 4th annual Quality Manufacturing Conference, in collaboration with FDA and PQRI. Lachman Consultants is the sponsor of the Welcome Reception as well as the conference badges. In addition, we will be exhibiting in the hall at table 3. Please stop by our booth for a chance to win an iPad,

Terri Nataline and Fran Zipp Present at the 5th Annual Global Pharma Regulatory Summit

On April 25, Terri Nataline and Fran Zipp participated in a summit focusing on global strategies for Indian pharmaceutical companies, the Annual Global Pharma Regulatory Summit, in Mumbai, India. This summit brings together global regulators who shared their knowledge about complying with international regulatory guidelines for manufacturing and exporting pharmaceuticals. Terri Nataline, Principal Consultant, presented in 2 sessions dealing with US FDA specific requirements,

Fran Zipp Presents at the Generic International Summit

On April 21, President and CEO of Lachman Consultants Fran Zipp gave a presentation at the 6th Annual Generic International Summit (GIS) in Shanghai, China. Her talk, “Data Integrity and Quality Culture” was part of a session on “Consistency Evaluation and Formulation”. She discussed the history of Application Integrity Policy (AIP), recent trends in data integrity related enforcement actions in the US and ex-US,

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 productive meeting for LCS.

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 related industries.