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.
I am pleased to announce that effective January 1, 2016, Frances “Fran” Zipp is President & Chief Executive Officer of Lachman Consultants.
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.
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on.
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.
Lachman Consultants recently exhibited at BioProcess International Conference and Exposition at the Hynes Convention Center, Boston, MA.
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.
FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose,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
Well, as someone who routinely reviews regulations.gov 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 regulations.gov,
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.
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,
The day after we reported on ANDA receipts, Approvals and Tentative Approvals, the Office of Generic Drugs (OGD) updated and revised its Activities Report of the Generic Drug Program for FY 2015. The update was through June but, again, not all data fields were updated.
The date to comment is being extended to June 8, 2015, based on requests from the industry for more time to digest the Rule.
There are so many issues covered by the Proposed 505(b)(2) and ANDA Rule that we can fill a book with the explanations (and we almost have). But we are giving you the Readers Digest condensed version in these posts. Be certain to read the entire Proposed Rule and watch for comments on Regulations.gov to get an idea of which sections will provide more controversy than others.
There are certainly some interesting issues that are going to be codified if the Proposed Rule publishes in final the way it is currently written. Many of the proposals are being formalized into the regulations that represent the Agency’s past practice. Here are highlights of a few more of some of these important issues that should be of interest to our readers.