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) […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
