Ashland announced the(FDA Center for Drug Evaluation and Research Office of New Drugs has accepted Ashland Viatel™ bioresorbable mPEG-PDLLA pharmaceutical excipient in the review cycle of the FDA Novel Excipient Review Pilot Program. The voluntary program is t...
As the need for novel excipients has never been greater, we are optimistic that a successful pilot program will lead to a formal novel excipient review program in the near future,” says Nigel Langley, Global Technology Director at BASF and a Chair of IPEC-Americas. BASF is a leader in ...
The proposed FDA pilot program is the first solid development following many years of effort on the part of excipient suppliers, pharmaceutical companies, IPEC-Americas, the IQ Consortium, and USP to reach out to and educate the agency on this important issue. “For the first time, we are se...