Revision to the Guidance “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017”

Today, the FDA issued Revision 1 to the above-referenced guidance.  According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’  This draft guidance addresses changes in user fee assessments from GDUFA I,

Michelle Ryder, new Principal Consultant in the Regulatory Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Michelle Ryder has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective October 28, 2019.

Ms. Ryder is a seasoned Regulatory professional with more than 20 years of experience in the pharmaceutical industry.  She has provided strategic leadership and plans for ANDA,

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Drug Shortages Report Provides Look Forward

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem.  Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy.  There has even been one firm created expressly to aid hospitals to avoid or resolve drug shortages.

Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern?

I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks (here).  The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no safety concerns for marketed products. 

Notice of Opportunity for Hearing Proposal to Withdraw Two ANDAs Implicates Cetero BE studies

In two separate Federal Register (FR) Notices on the FR prepublication page (here and here), the FDA proposed to withdraw approval of two ANDAs based on lack of confidence in the bioequivalence data contained in the applications.  The concern relates to a problem at a bioequivalence testing laboratory.  The Notices state:

“In May 2010 and December 2010,

Homeopathic Drugs Moving Closer to the Front Burner

The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products.  This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017.

Have Postmarketing Study Requirements? You May Want to Read This!

FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.  If you have any post approval study requirements for any of your products, you should pay close attention to this document.

In describing the document, the Agency says:

“This guidance describes FDA’s statutory authority to require certain postmarketing studies and clinical trials under section 505(o)(3) of the FD&C Act (i.e.,

Q&A Document Issued for Manufacturing Facility Information

The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc.

The document provides specific guidance on what, where, and how to list such information in the 356h and in the relevant modules of the application. 

Draft DMF Guidance Issued by FDA

A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989.  There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs,

First Official Metrics Out for September & OGD Smashes FY ANDA Approval Record – Could It Have Been Better?

For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in FY 2018. 

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New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program.  The Federal Register Notice (here) announcing the availability of the guidance states:

“This guidance describes the types of waivers,

Closeup of woman smoking electronic cigarette

E-Cigarettes – What Will Be Their Fate?

In thinking about the current vaping issues, which have been associated with a significant number of deaths and hundreds, if not thousands, of lung-related injuries, I think the path to the future of these products needs to be critically evaluated by the FDA.  The introduction of e-cig came so fast that the FDA was not prepared to deal with the issue. 

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 [...]
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