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MaPP 5310.3 on Expedited Review of PAS Supplements for NDAs and BLAs Tracks the Generic Process

The Office of Pharmaceutical Quality (OPQ) today published a Manual of Policy and Procedures (MaPP) document titled Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes (here) for new drug applications and biologic license application holder that submit a prior approval supplement and seek expediated review. 

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ICH Q7 cGMPs for APIs Q&A Guidance Issues

Today, FDA published guidance titled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Questions and Answers.”  FDA explains that, since ICH Q7 has published, there have been many questions raised by firms, both domestic and international, requesting clarification on issues raised in the ICH document.

The Q&A document referenced above responds to those questions. 

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Got Some Time on Your Hands – New Quality Guidance for MDIs and DPIs Issues

On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”.  The original guidance was published November 13, 1998.  The revision spans some 50 pages of discussion about critical quality attributes,

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Paragraph IV Certifications Last 4 Plus Years

Almost everyone in the generics industry is familiar with the FDA Paragraph IV database (aka list).  As described by the Agency, the list is published “[a]s part of its ongoing efforts to assist generic drug applicants in preparing their applications, FDA regularly publishes a list of drug products for which an ANDA has been received by the Office of Generic Drugs (OGD) containing a Paragraph IV patent certification.

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So How is that Prescription Drug Imported On-line from Canada?

With all the discussions of reducing prescription costs, the importation of drugs from Canada almost always appears in the debate.  While there are many reputable Canadian on-line and brick and mortar pharmacies from which to import prescription drug products, I have never thought that it was a good idea.  ABC News (here) seem to validate my opposition.

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FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions

We do not often blog on the issue of dietary supplements but in this case the FDA is making a serious point by issuing a guidance entitled “Highly Concentrated Caffeine in Dietary Supplements” which can be found here. This comes after several deaths from consumers taking lethal doses of pure or highly concentrated powers or liquid caffeine containing products.

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New Grant Applications Sought for Topical Products

The FDA has struggled with the best methods to determine the bioequivalence of topical dermatological drug products for years. For example, FDA considered numerous methods including transepidermal water loss (TEWL), skin stripping, and others to demonstrate the bioequivalence of retinoid acne products.  None were found acceptable and the Agency ultimately relied on bioequivalence studies with clinical endpoints to approved generic versions of these cream,

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Outsourcing Facilities Make the News Again

On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here).  Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency.  Today’s announcement highlights a continued sterility assurance concern by the FDA.

Donna Gulbinski, new Vice President, Compliance Services at Lachman Consultant Services, Inc.

We are pleased to announce that Donna Gulbinski has accepted the position of Vice President, Compliance Services at Lachman Consultants, effective April 9, 2018.  In this new role, Donna will report directly to me.

Ms. Gulbinski is a proven global quality leader who delivers strategic quality, compliance, and business performance services to Lachman and our clients. 

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Approvals Spring Back to Life in Spring – A Look at March and Other Statistics

OGD just released its March 2018 ANDA Approvals and receipts data.  The results are even stronger than reported earlier (here).  March officially saw 56 full approvals and 11 tentative approvals, a few more than we saw on April 3rd, as the databases became fully populated over the next few days.  None of the approvals or tentative approvals were reported as first cycle approvals in the March report.

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March Shows More OGD Approval Recovery from the EI Issue

March approvals appear to be moving in the right direction as firms, apparently, are catching up with elemental impurity issues and their amendments are working their way through the review and approval process.  Unofficial March ANDA approval numbers taken from the Recent New and Generic Drug Approvals list (here) show 50 full approvals and 10 tentative approvals.