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The FDA wants drugmakers to identify the analytical procedures used to generate stability data in their new drug application (NDA) or abbreviated new drug application (ANDA).
The FDA said it plans to finalize its cGMP guidances on process analytical technologies (PATs), aseptic processing, comparability protocols (CPs), and formal dispute resolution later this year, but no new draft guidances on GMP and International Conference on Harmonisation (ICH) initiatives will be issued.
Drugmakers should be allowed to submit a comparability protocol (CP) when a chemistry, manufacturing and controls (CMC) change is made or when the production site changes, which according to PhRMA is a much more efficient process.
The FDA needs to offer more detail on how the proprietary interests of drugmakers would be protected in its draft guidance on pharmacogenomics that calls for voluntary genomic data submissions (VGDSs), Eli Lilly told the agency in recent comments.
The FDA wants to ensure that drugmakers and other sponsors of clinical trials for new drugs that treat serious or life-threatening diseases provide more information about the trials to patients who may not meet the study’s eligibility criteria.
Purdue Pharma has petitioned the FDA to withhold final approval for a version of its profitable pain drug OxyContin until generic firms implement appropriate risk management plans (RMPs) — a move that could delay generic competition.
Generic drugmakers Ivax and Dr. Reddy’s are scheduled today to start challenging a patent on drugmaker Eli Lilly’s top-selling schizophrenia drug Zyprexa (olanzapine).
Brand manufacturers that are the sole provider of a drug sold to hospitals may see increased sales under new federal reimbursement rates established in the Medicare prescription drug law.
Decisions on whether a clinical cancer study should be exempt from investigational new drug (IND) regulations will no longer be based solely on the size of the study, the FDA stated in a revised guidance issued earlier this month.