FDA guidance entitled "Changes to an Approved NDA or ANDA" published in the Nov. 23 Federal Register; copies are available on the agency's Web site (www.fda.gov). FDA published a draft guidance on the subject June 28 ("The Tan Sheet" July 5, p. 18). The guidance provides recommendations to NDA and ANDA holders who intend to make post-approval changes in accordance with section 506A of the FDA Modernization Act, which rewrites FDA's Sec. 314.70 manufacturing regs. Categories addressed in the guidance include: "components and composition, manufacturing sites, manufacturing process, specifications, package [and] labeling." In response to comments on the draft, FDA changed certain language in the guidance regarding examples of an annual report change; language pertaining to "sterility assurance" was kept the same, however. For further information, contact CDER's Nancy Sager at (301) 594-5633
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.
The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.
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.
