Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development

Aloka Srinivasan, Vice President, Regulatory Practice at Lachman Consultants recently wrote an article for PharmTech, detailing the Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development. The article provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or [...]
Old Way x New Way Crossroad

Are All Methods Equivalent?

The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated.  Alternate methods can be easier to use and, in some instances, more accurate and reliable.  But how can you demonstrate that an alternate method is indeed equivalent to an existing method?

Law and justice concept

California Governor Got it Wrong on Pay-for-Delay!

While California is usually a very progressive state, I believe that Governor Newsom did not quite understand the implications of the bill he signed into law banning pay-for delay patent settlements.  I believe he failed to see that not all pay-for-delay cases are anticompetitive.  According to the Association of Accessible Medicines (AAM) statement about the bill:

“As the Federal Trade Commission has found,

Beautiful Hispanic Woman Analyzes Statistics, Charts and Pies with Company's Growth Shown on a Wall TV.

OGD Updates August 2019 Metrics

August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications.  Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review applications submitted each month. 

Just Say No! Not a Good Idea for a Testing Lab

In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory.  The FDA takes refusal of inspection very seriously and the impact on NDA or ANDA sponsors (or,

Vasopressin Verdict May be Precedent for Drug Companies Seeking to Protect Approved Products

In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community.  The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first approval through an NDA process. 

stack of one hundred dollars notes

New Fees Announced for Use of Priority-Review Vouchers

In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here).  Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for a specific drug or biologic that meets the regulatory and statutory provisions of the relevant acts,

Human resources restructuring process illustrated on blackboard

CDER Office of New Drugs Reorganization and Impact on OPQ and Office of Translational Sciences Announced

CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here).  The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise.  The FDA says, “the changes increase the number of OND offices that oversee our review divisions from six to eight—and increases the number of OND clinical divisions from our current 19 divisions to 27,

Athlete Jumping over Hurdles

Compounding vs. FDA Approved Product Presents a Conundrum Regarding the Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor

Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]).  The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints. 

Woman on the phone looking confused at a broken computer

Don’t Panic – ANDA Approvals Continue To Roll Along – But A Glitch Might Not Make Them Immediately Visible

I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here).  

Petition Form

Revised 505(q) Petition Guidance Published

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that were submitted to the Agency after the original draft was introduced in 2018. 

Continuous Manufacturing and its Regulatory Challenge

So, what is the buzz about continuous manufacturing (CM)? What benefits does it bring to the manufacturer and what are the regulatory challenges? The author of this Contract Pharma article, José L. Toro, Ph.D. of Lachman Consultants, discusses the current thinking on the benefits of CM and the regulatory hurdles a manufacturer has to overcome. [...]
Printout of a DNA sequence chromatogram

Extraneous Chromatographic Peaks – What’s a Lab to Do?

Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i].  This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations.