Drugmakers Lose Time, Money With Mistakes About CDER’s Policies

Too many drugmakers are left dealing with warning letters and complete response letters after finding they didn’t meet CDER’s expectations for drug trials or manufacturing.

Recently, the FDA handed ViroPharma a complete response letter on its industrial scale manufacturing supplement for hereditary angioedema drug Cinryze, citing concerns about a portion of the cleaning validation.

The agency made three comments, one of which requires additional unplanned action, ViroPharma said.

And late last year, the FDA has issued a complete response letter asking Alimera Sciences for two more clinical trials for macular edema treatment Iluvien (fluocinolone acetonide) — studies the company said are likely to be long.

Many pharma giants would love to be a fly on CDER’s walls to know how and when their applications, schedules and reports will be reviewed by the FDA. But there’s no need to go to that much trouble. FDAnews has just the right tool for you: The CDER Sourcebook.

This all-new edition of FDAnews’ best seller provides an overview of each of the CDER policies that are important to you, as well as the full-text versions of those 150 policies in a fully searchable CD-ROM.

Align your own policies and practices with CDER’s own decision-making procedures by ordering this book today.