Study: Speedier reviews might have compromised rigor of FDA approval

USA – Study: Speedier reviews might have compromised rigor of FDA approval

Changes in U.S. Food and Drug Administration (FDA) procedures meant to speed approvals for medications may have resulted in less exacting standards, a new...
Pediatric Study Plans for Oncology Drugs : Q & A

USA – Pediatric Study Plans for Oncology Drugs : Q & A

The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by...
3 More NDAs Will Become BLAs

USA – 3 More NDAs Will Become BLAs

As some insulin, human growth hormone and other products transition on 23 March from new drug applications (NDAs) to biologics license applications (BLAs), the...
Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

USA – Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

Law firm Hyman, Phelps & McNamara (HP&M) last week filed a citizen petition on behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx)...
FDA Warns of Potential Cancer Risk With Weight Loss Drug

USA – FDA Warns of Potential Cancer Risk With Weight Loss Drug

The US Food and Drug Administration (FDA) on Tuesday alerted the public to the results from a clinical trial that showed a possible increased...
La compagnie de tests génétiques 23andMe a développé un médicament grâce à l'ADN de ses utilisateurs

USA – La compagnie de tests génétiques 23andMe a développé un médicament grâce à...

La compagnie de tests génétiques 23andMe vient de vendre les droits d'un médicament qu'elle a pu développer en utilisant les données de santé récoltées chez...
FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete

USA – FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study...

In the latest update in the years-long investigation into the safety of Bayer’s permanent birth control device Essure, the US Food and Drug Administration...
More drugmakers recall nizatidine, ranitidine products over cancer risk

USA – More drugmakers recall nizatidine, ranitidine products over cancer risk

The series of recalls of ranitidine (also known as Zantac) and nizatidine products grew longer with three US Food and Drug Administration (FDA) announcements...
FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports

USA – FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports

The US Food and Drug Administration (FDA) on Wednesday said it plans to withdraw the approval of 249 abbreviated new drug applications (ANDAs) after...
NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses

USA – NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses

Congressional action is necessary stop pharmaceutical companies from abusing the Orphan Drug Act, filing sham citizen petitions and extending the market exclusivity for products that...

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