FDA will be issuing discipline review letters and information request letters to generic drug applicants to communicate shortcomings in ANDAs. Under GDUFA II, the US agency agreed to send out these letters at the mid-point of the review clock.
FDA Dec. 15 issued draft guidance explaining its procedures for issuing discipline review letters (DRLs) to communicate deficiencies found in abbreviated new drug applications as well as information request (IR) letters where information is lacking.
FDA agreed under the Generic Drug User Fee Amendments of 2017 to sending out these letters midway through the first...
Create an account to read this article
Already a subscriber?
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.
Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
