November 2019

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 […]

Read More
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, […]

Read More
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 […]

Read More
02
Nov

Former FDA and Regulatory Experts from Lachman Consultants, Inc., to Serve as Panelists at AAM GRx & Biosimilars Meeting

(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, […]

Read More
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 […]

Read More
1 2 3