The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.
Brief pharmaceutical news items for September 2009.
After years of promomting QbD concepts, FDA's ready to take action on nonconformers.
Robotic systems provide flexibility and efficiency (and they're not as difficult to use as you think). This article contains bonus online-exclusive material.
Authenticating tools help identify counterfeit drug products. This article contains bonus online-exclusive material.
As new process validation guidelines emerge, industry needs to reinvent how it releases product.
Why correctly calibrating a drug with its packaging is the key to success.
Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more...
Researchers from a university in the US are urging the FDA to demand that drug manufacturers state how new medications compare with similar treatments on product labels.
Amcor (Australia) has made an offer of $2025 million for parts of Alcan Packaging (France), including the company's global pharmaceuticals division.
Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more...
Researchers from the Stanford University School of Medicine in California are urging the US Food and Drug Administration to demand that drug manufacturers state how new medications compare with similar treatments on product labels.
Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more...
Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...
Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...
Editors' Picks of Pharmaceutical Science & Technology Innovations
Biotech firms must first close the gaps between science and biology on the path toward QbD.
An expanding number of products and services plug gaps in the cold chain. This article contains bonus online-exclusive material.
Individuals and companies at the top seem to have no problem short-circuiting their success.
Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...
Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more...
Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more...
Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more...
Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more...
The regulators are doing it. But industry's fear of sharing information may leave them behind.