Submit good REMS proposals for FDA brownie points, says RAPS author

By Natalie Morrison

- Last updated on GMT

Related tags: Firm

Submit good REMS proposals for FDA brownie points, says RAPS author
Submitting a REMS (Risk Evaluation and Mitigation Strategies) proposal for risky drug developments could earn companies brownie points, according to Quintiles’ Ed Tabor.

The firm’s VP of strategic drug development wrote a book about the changes – first introduced in 2007 – for RAPS (Regulatory Affairs Professionals Society).

Speaking to, he said the programme has the power to change how firms work with the FDA (US Food and Drug Administration).

“A good regulatory strategy always involves thinking ahead and using those predictions for strategic purposes,”​ he said.

“If a company has a drug under development, and they know it has a safety issue if they come to FDA with a REMS proposal that adequately addresses those it means that the review division is going to think of the company as proactively concerned about safety.”

He added proving your firm is concerned with safety for a drug under the approval process now could also earn brownie points in the future.

Tabor also spoke about the regulator’s current review process of the recently introduced programme.

And though the industry does not yet have the full seven year evaluation, he said the feeback so far has been positive.

Related topics: Markets & Regulations, QA/QC, Regulations

Related news

Show more

Related products

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more