Generics

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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05
Nov
The Question of Generics and Emerging Technology Image

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 […]

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05
Nov
Keeping an Eye on The Ultimate Goal Image

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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04
Nov
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

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 […]

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01
Nov

First Month of FY 2020, October Approval Numbers Look Like Tail of 2019

I am pleased to report that the approval and tentative approval actions are again appearing on the daily approvals and All Approvals listing on the FDA website again.  So far, it looks like another of the slower months for approval and tentative approval actions to start off the new fiscal year.  To date (through October […]

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31
Oct
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Image

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 […]

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30
Oct
Drug Shortages Report Provides Look Forward Image

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 […]

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16
Oct

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 […]

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