The draft guidance documents were published in a Federal Register announcement on 14 September 2018. The guidances are intended to assist applicants when it comes to making generics of complex drugs. Of the guidances issued, 12 are new draft guidances and six are revised guidances for complex drug products, including 14 products that, to date, do not have generics’ competition.

Product-Specific Guidances for Generic Drug Development
Date:September 2018
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm

FDA Commissioner Scott Gottlieb said that the agency is ‘providing recommendations for some new generic drugs’ but ‘is also modernizing some of its previously issued guidance to make sure they reflect the most efficient path for developing generics’.

The agency believes that ‘increased transparency on product-specific guidances gives manufacturers seeking to develop generic copies of medicines, including complex drugs, a better opportunity to efficiently allocate drug development resources’.

FDA says that providing ‘greater access to high quality generic drugs’ is one way the agency ‘is working to improve competition and promote access to important medicines and advance the public health’.

FDA is seeking public comment on the draft guidance documents. Comments and suggestions should be submitted within 54 days of publication in the Federal Register, i.e. by 13 November 2018. Comments can be posted to the Dockets Management Staff under Docket No. FDA-2007-D-0369. This can be done via the website www.regulations.gov or written comments can be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

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