man think how to solve the problem

The Complexity of Complex – Explained at Least in Part

On Wednesday afternoon at AAM’s GRx+Biosimilars Conference in Bethesda, MD, the FDA held a valuable workshop on Complex Generic Drug Products.  The workshop opened with a general session explaining the opportunities for interacting with the FDA to get guidance and input while developing your complex generic and preparing your ANDA and how to get the most out of these interactions.

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Now That the ANDA is Approved…What Do We Do with It?

On the last day of at the Association for Accessible Medicines GRx-Biosims conference in Bethesda, members of the FDA joined industry for an informative and interactive discussion on post-approval supplements.  Dr. Paul Schwartz and his colleague Olugbenga Okubadejo expressed satisfaction with the current state of the post-approval supplement process, as well as the example of teamwork it has taken to get it there (both within the FDA and also in partnership with industry).  

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It Is All About the “Risk”

Is there a Pre-Approval Inspection (PAI)? When will it be?  Will our site be inspected?  The anxiety-tinged queries from production (and management) personnel start almost as soon as an application is submitted, and until now regulatory personnel had little answers to offer except vague reassurances like, “We have to wait and see” or “It’s up to OPQ”.  

Audience Perspective – Both Sides of the Controlled Correspondence Story; One Common Problem

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, members of the FDA and industry came together to present opinions and discuss the Controlled Correspondence process.  Controlled Correspondence (CC) between the FDA and industry is very much like an important pen pal relationship (where you only write to each other regularly, but never meet).  

Drug/Device Combination Products, Challenges and Opportunities

On the second day of AAM’s GRx-Biosims Conference, in Bethesda, Maryland, a session was held related to drug/device combination products.  The session included several presenters from the FDA and industry.  While the challenges with the drug/device combinations was well covered in the session, there wasn’t a lot of focus on the opportunities.

The industry,

Global Regulatory Harmonization for Biosimilars

The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success.  This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products.

On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) spoke on The Importance of Global Regulatory Harmonization for Biosimilars. 

The Answers May be in What Is Not Stated – Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process

An interesting session during the GRx+Biosims conference held in Bethesda on November 4, 2019 addressed Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process.  The presentations from the FDA, as well as industry, acknowledged that the adequacy of drug master files (DMFs) for APIs in one cycle has been a lot more challenging compared to that of the first-cycle approval of ANDAs.  

Office of Compliance Reports Country Warning Letter Winner for 2019 Flip

Donald Ashley, JD, Director of the Office of Compliance at CDER reported a rather surprising statistic relative to the country that received the most warning letters in FY 2019!  And the winner is – the United States!  Domestic firms received 54 warning letters, followed by India with 17 and China with 14.  Previous years had India or China with the dubious distinction of being issued the most warning letters.

OGD Director Provides Update On Generic Program

Dr Sally Choe, Director, Office of Generic Drugs, outlined the actions that OGD has taken for outreach to stakeholders, citing the many workshops and seminars in which OGD participated.  She provided a view of the GDUFA regulatory science initiatives, including guidance on complex products, internal alignment on complex issues, confidence in generic substitution, review tool development,

The Question of Generics and Emerging Technology

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, FDA called on Generic firms to be involved and participate in innovation and FDA’s Emerging Technology initiative.  We heard that innovation was not something that should be limited to just Brand Companies.  But, in the field of Generics, where Q1/Q2 and sameness or interchangeability is key,

Keeping an Eye on The Ultimate Goal – How to Ensure Success In Developing Complex Generics

One of the popular sessions in GRx+Biosims Conference held in Bethesda on November 4, 2019 was about Developing Complex Generic Products – How to Ensure Success. The session involved presentation and discussion by FDA and industry. Both sides agreed that the most important factor in assuring success in the development of complex generic is communication,

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AAM GRx-Biosims Meeting Day One Morning Highlights

The GRx-Biosims 2019 meeting started off with a meditation and stretching exercise; after that, we had to put our minds to work and begin exercising out neurons.  Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, provided an update on generic drug activity, action plans, and biosimilars.  Key points and highlights were:

  • Record breaking number of ANDA approvals in FY 2019 (935)
  • 125 first-time generic approvals
  • 138 approvals for complex generics
  • 205 product-specific guidances
  • The use of the Mutual Recognition Agreement with the EU on inspections designed to keep regulatory authorities from duplicating inspectional efforts
  • FDA has approved twenty-three biosimilars
  • However,

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,