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In fiscal year 2021, US FDA approvals for complex generic drugs accounted for more than 13% of all simplified new drug application (ANDA) approvals.
Since fiscal year 2017, approvals for complex generic drugs have shown a steady increase
.
As the share of complex product applications gradually increases, FDA may need to adjust its internal staffing and other resources to adapt to the changes
The US FDA Office of Generic Drugs (OGD) Research and Standards Office Robert Lionberger stated at the Association of General Medicines (AAM) GRx-Biosims meeting on November 10 that the industry has more room for growth
.
He said that given that 25% of all new drugs or reference products are considered complex, they are generally still below market demand
Lionberger added that as more and more sponsors seek approval for complex generic drugs, the FDA is ready to make adjustments
.
"Things are slowly changing
The upcoming reauthorization of the Generic Drug User Fee Program includes funding for the hiring of 128 additional full-time employees
.
This includes some employees who will handle complex generic drugs
The number of filings has grown faster than approved
The number of filings has grown faster than approved It’s no surprise that applications for complex generic drugs are growing faster than approved
.
The share of complex generic drug declarations in all declarations increased from 13.
From FY 2017 to FY 2021, the share of complex generic drugs in ANDA approvals has grown much more slowly
.
In FY2017, complex generic drugs accounted for 12% of the 763 approvals (approximately 92)
The approval process for complex generic drugs can be slow and require multiple review cycles
.
Typically, these drugs are paired with delivery devices that may cause problems for demonstrating bioequivalence
More improvements in the approval of complex generic drugs
More improvements in the approval of complex generic drugs The FDA and industry have been looking for ways to increase communication before and during ANDA reviews to increase the first round of approvals and reduce the total number of evaluation cycles for complex products and other products that require approval
.
During the GDUFA III negotiations, industry and FDA representatives negotiated improvements to the mid-term and full response letter meeting, in part to help simplify the approval of complex generic drugs
