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.
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.
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.
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,
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,
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:
(Westbury, NY— November 2019) Two top FDA and industry experts from Lachman Consultant Services, Inc., (“Lachman Consultants”) will be participating as panelists at The Association for Accessible Medicines (AAM) Generic (GRx) and Biosimilar (Biosims) Conference, also known as AAM GRx+Biosims, on November 4-6, 2019, at the Bethesda North Marriott Hotel & Conference Center in Bethesda,
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 30),
