FDA Introduces Guidelines to Ease Approvals for Generics


The changes included new draft guidelines and improved clarity of the requirements.

Scott Gottlieb, FDA, Opioids

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb (pictured) announced Monday that the process to get complex generic drugs through approval will become more simplified.

The commissioner announced several initiatives that will quicken the approval of generics, including draft guidance for pre-abbreviated new drug application (ANDA) meeting requests, which will allow the FDA additional ease in providing quality advice to pharmaceutical companies that are attempting to develop complex generics.

"The new policies we're announcing today are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs," Gottlieb said in a statement. He also announced a draft guidance to aid in determining when it would be appropriate to submit ANDAs for peptides.

Gottlieb added that the guidance applies to very specific products, such as glucagon, liraglutide, nesiritide, teduglutide, and teriparatide, all of which are branded products that have been manufactured with recombinant DNA technology.

There was an additional note by the commissioner that advances in technology have allowed for the synthesis of peptides and characterization of peptides allow applicants to better clarify the “sameness” of their products in order to meet genetic regular clearance guidelines. He confirmed that the new guidance will aid in identifying the risks of immune responses from generics due to "differences in impurities will not differ from that of the reference drug."

Additionally, the FDA today announced a new dashboard for its Adverse Event Reporting System (FAERS) to make it more easily accessible and allow for better information to be accessed by patients and professional.

Gottlieb has made a number of announcements and kick-started a batch of initiatives since being named the FDA commissioner earlier in 2017. Since, he’s gone to revamp opioid regulation, including adjusting the FDA’s stance on buprenorphine and methadone, partnered with Interpol to crack down on illegal online pharmacies, and made changes to improve generic drug options.

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