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Contamination and Raw Material Testing Issues Raised in FDA Warning Letters

 
• By Joanne S. Eglovitch

FDA investigators are continuing to find contamination problems and inadequate testing, according to 20 warning letters issued in the first half of 2013, as well as a troubling trend of repeat observations at Baxter, Hospira and Apotex. Observers say to expect more sterility concerns in future warning letters, particularly involving mold, as FDA ramps up GMP enforcement at compounding pharmacies.

Inadequate control of contamination continues to be a common problem found in drug GMP warning letters, while insufficient raw material testing is a growing problem seen in the 20 drug GMP warning letters FDA issued in the first half of 2013.

Observers also say to expect more sterility problems, such as mold, as FDA ramps up its GMP enforcement of compounding...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.