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.

GDUFA II Negotiations and FDA Trends

We all know that the GDUFA II negotiations are in full swing.  Among topics being discussed are fee issues associated with small businesses and especially the subject of establishment fees and whether they should be collected only after ANDA approval.  This is also on the radar of Congress and will likely get some significant attention in the negotiation discussions.

Have We Come Full Circle? 

Dr. John Peters, the newly appointed Deputy Director of OGD, just posted a piece on the FDA website on the “Importance of the Physical Characteristics of Generic Drugs”. Dr. Peters also noted that OGD has taken a particular interest in what he termed “Patient-Focused equivalence” or something that I have termed “functionality” when I have been questioned about whether the concept of generic drug “sameness” had taken on new definitions.

2015 ISPE Annual Meeting

Fran Zipp, President of Lachman Consultants, presented at the 2015 ISPE Annual Meeting, November 8-11 at the Philadelphia Marriott Downtown. She spoke about the launch of the ISPE Drug Shortage Assessment and Prevention Tool, on Monday, November 9 at 10:45 AM. For a preview of the tool, please see this article authored by Fran in November’s issue of Pharmaceutical Engineering.

To Compound or Not to Compound? That is the Question!

To Compound or Not to Compound? That is the Question!

FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use in the compounding of drug products and has described its interim enforcement policy regarding drugs compounded under Section 505 A (dealing with pharmacy compounding) and Section 503 B (dealing with outsourcing facilities) of the Federal Food Drug and Cosmetic Act.

Single Patient Use – A New Label Term for Parenteral Products

FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. This draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms

FDA to Publish ALL Comments Submitted by Individuals to Dockets on

Well, as someone who routinely reviews postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through.  Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to,

MaPP to Nowhere Now has Coordinates to Find the Treasure

or those of you who troll the CDER web page, you may have noticed that the Office of Generic Drugs (OGD) posted a revision of MaPP 5200.3 entitled “Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications” last night. OGD’s issuance of revision 1 of the MaPP clearly provides industry with much of what they have been asking for.

FDA Clarifies Issues Regarding Outsourcing Pharmacies

The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.”  Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food,