SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Headlines > Regulatory & Safety

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

By Natalie Morrison , 13-Jun-2012

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

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 in-PharmaTechnologist.com, 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.

Subscribe to our FREE newsletter

Get FREE access to authoritative breaking news, videos, podcasts, webinars and white papers. SUBSCRIBE
Catalent launches softgel products at CPhI: one vegetarian, one anti-abuse

Catalent launches softgel products at CPhI: one vegetarian, one anti-abuse

Will Downie

Senior VP Global Vusiness Development & Marketing, Catalent

AlpVision's iPhone Tech Offers Authentication in War on Counterfeits

AlpVision's iPhone Tech Offers Authentication in War on Counterfeits

Quincy Mattingly

Regional Manager, AlpVision

Customers to Save up to 65% as ASI and Chromatan Pen Single-Use Deal

Customers to Save up to 65% as ASI and Chromatan Pen Single-Use Deal

ASI has teamed up with Chromatan in order to deliver single-use and column-free capture...

Updated IPEC Guide Steers Excipient Manufacturers Away From Unnecessary Tests

John Giannone - incoming IPEC-Americas chairman

Irwin Silverstein, COO and VP of the International Pharmaceutical Excipients...

ATMI: Single Use Bioreactors on the Up, but US Tails Europe

ATMI: Single Use Bioreactors on the Up, but US Tails Europe

Special Report from ATMI's Belgian Facility

BASF nutrition president on high-end omega-3, Equateq and the phood “white space”

BASF nutrition president on high-end omega-3, Equateq and the phood “white space”

Walter Dissinger

President , BASF nutrition and health

Optimism is returning to the pharma fine chemicals sector, says analyst

Optimism is returning to the pharma fine chemicals sector, says analyst

Jan Ramakers

Industry consultant, Jan Ramakers Fine Chemical Consulting Group

Capsugel expands liquid fill capsule capabilities

Keith Hutchison,

Senior VP of research and development (R&D) , Capsugel

New filtration tech boosts biomanufacturing yields, says Sartorius

New filtration tech boosts biomanufacturing yields, says Sartorius

Jens Meyer

Product manager for filtration technologies, Sartorius Stedim

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

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

Ed Tabor

VP of strategic drug development , Quintiles

Capsugel: Micro-Dosing Tech Can Cut Drug Development by 6 Months

Capsugel: Micro-Dosing Tech Can Cut Drug Development by 6 Months

Missy Lowery

Marketing Manager for the Americas, Capsugel

Thermo Fisher: Single-Use Tech's Evolution and Increased Industry Use

Thermo Fisher: Single-Use Tech's Evolution and Increased Industry Use

Cory Stevenson & Brandon Pence

Thermo Fisher Scientific

ATMI: Single-Use Could Replace Multi-Use, as Potency Increases

ATMI: Single-Use Could Replace Multi-Use, as Potency Increases

Eric Isberg

Global Product Manager, ATMI

Tech and Regulatory Issues? Biotech/Manufacturing Firms Discuss

Tech and Regulatory Issues? Biotech/Manufacturing Firms Discuss

Purification bottlenecks, integrating single-use technologies and low cost companies are just some of the...

Happy holidays from William Reed Business Media!

Happy holidays from William Reed Business Media!

The working year is almost done, time to pause from ‘the business’ and embrace...

Key Industry Events

 

Access all events listing

Our events, Events from partners...