November 2019

08
Nov
Now That the ANDA is Approved Image

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 […]

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07
Nov
Gottlieb Tells Attendees at GRx-Biosims Image

Gottlieb Tells Attendees at GRx-Biosims Conference About His Term as Commissioner

Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner.  Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues: Gaming the system through REMS and restricted distribution […]

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07
Nov
It Is All About Risk Image

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 […]

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06
Nov
Audience Perspective Image

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 […]

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06
Nov
Drug Device Combination Products Challenges and Opportunities Image

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, as […]

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06
Nov
Global Regulatory Harmonization for Biosimilars Image

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) […]

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06
Nov
The Answers May be in What Is Not Stated Image

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 […]

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05
Nov

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 […]

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05
Nov
OGD Director Provides Update On Generic Program Image

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 […]

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