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  Pharmaceutical Technology Europe E-Alert
 
18 March 2011

IN THIS ISSUE
J&J consent degree
New FDA guidance
Foreign inspections
PTE March

 
FDA files consent decree against Johnson & Johnson
The FDA has filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with cGMP requirements. More...
 
FDA Issues guidance on user fee waivers, reductions and refunds
The FDA has issued draft guidance titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). More...
 
Industry urges for reform in FDA foreign inspections
A number of industry bodies, including the Bulk Pharmaceutical Task Force of the Society for Chemical Manufacturers and Affiliates (SOCMA), are calling on the FDA to mandate inspections of foreign API manufacturing sites with the cost borne by those sites being inspected. More...
 
Quack, quack!
Have you seen the latest issue of Pharmaceutical Technology Europe? The March issue includes articles on particulate contamination risk, tablet tooling standardisation and a special feature on the challenges of granulation. More...
 
US senate passes patent reform bill
The US Senate has approved the "America Invents Act," which will, if it becomes law, establish a first-to-file system by defining an invention's effective filing date as the actual filing date of the patent or patent application. More...
 
Join our community on LinkedIn
Want to discuss any of this week's news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More...

Latest blog posts
Raising the bar in outsourcing
Consent decree (finally) for J&J
Who loves tablets?
More blog posts

Latest articles
Drug scandal shocks France
Improving solid dosage forms with dry granulation
Magnetically controlling pills for better drug delivery
More articles

Upcoming events
IVT's 2nd Annual Validation Week EU (28–30 March | The Netherlands)
Interphex (29–31 March | USA)
BioTrinity 2011 (12–14 April | UK)
More events

Product Profiles
Catalent

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. Read more

 
Rotronic

The new HygroLog HL-20/21 series
The new HygroLog HL20/21 series is the latest development of data loggers for relative humidity, temperature, dew point and frost point. Read more

 
Wheaton

For more than 120 years Wheaton has developed innovative packaging concepts to meet the demanding needs of companies supplying critical biological and chemical based products to the marketplace.. Read more

 


Survey
Has the FDA's transparency initiative helped your company?
Yes, we've learned much more about the agency's operations and decision-making process 40%
 
No, we still have difficulty getting information from the agency 36%
     
It has had no impact 24%

This week we would like to know...

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