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Wrong telephone numbers, unsecure email addresses and inconsistent sponsor names are among the common mistakes the FDA sees in regulatory submissions for generics that can trigger delays in the review process. Read More
The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of introducing new priorities for this fiscal year — the final year of the five-year authorization for GDUFA I. Read More
Industry groups have endorsed the FDA’s commitment goals for BsUFA II, asking Congress to reauthorize the user fee program intended to improve review efficiency. Read More
The FDA’s commitment goals for GDUFA II were backed by industry at a recent meeting, bringing the user fee program closer to reauthorization. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More
The FDA’s draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments. Read More
The International Council for Harmonisation identified the key scientific issues facing drug developers in pediatric indications in a draft updating its 16-year-old E11 guideline. Read More
The FDA is recommending that sponsors submit more detailed race and ethnicity data with their applications, compared to recommendations from a previous international harmonization guideline. Read More
The FDA withdrew a rule proposed in 2001 that would have required the public disclosure of certain data related to unapproved human gene therapy or the transplantation of non-human tissues to humans from companies seeking approval of investigational new drugs. Read More
The HHS inspector general’s office laid out its agenda for the fiscal year, planning new and expanded reviews of the FDA’s oversight of blood establishments and laboratory-developed diagnostics; management of IT modernization initiatives; and its use of prescription drug user fees. Read More