CHPA Manufacturing Controls Seminar In Brief

Tainted "supplement" recalls soar: Products marketed as dietary supplements but containing active pharmaceutical ingredients were the subject of 80 class I recalls through the first three quarters of fiscal 2010 - compared to slightly more than 50 in 2009 and 10 in each of 2008 and 2007. Adulterated supplements are "blowing this off the chart," says Mike Smedley, deputy director of FDA's Division of Manufacturing Product Quality in the drug center's Office of Compliance. Rx and OTC pharmaceuticals together have totaled fewer than 20 class I recalls in 2010, said Smedley, speaking at the Consumer Healthcare Products Association's Manufacturing Controls Seminar Oct. 13-14 in New Brunswick, N.J. A class I recall is the most serious, denoting a product has potential to cause adverse health effects or death. Smedley said DMPQ recently established a data analysis team to identify root causes of recalls that may trend across multiple firms. FDA has prioritized enforcement against adulterated supplements, which often are marketed for weight loss, strength training or sexual enhancement (1"The Tan Sheet" June 21, 2010)

More from Archive

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

 

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 

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 

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

 

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

More from Pink Sheet

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By 

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.