Innovative technology can help develop treatments and vaccines for third world populations and national defense
Jul 1, 2007
By:
Jill Wechsler
Now equipment makers are designing new systems that can be deployed rapidly, are less costly to build, and require less water and power to operate.
|
Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality
Jun 1, 2007
By:
Jill Wechsler
FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.
|
May 23, 2007
By:
Jill Wechsler
Following the US Senate approval of the FDA Revitalization Act (FDARA, S.1082) in May, the debate over drug safety and the reauthorization of the Prescription Drug User Fee Act (PDUFA) now moves to the House.
|
Advanced product characterization methods may pave the way for biosimilar therapies
May 1, 2007
By:
Jill Wechsler
The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.
|
Too many postapproval manufacturing submissions impose a heavy burden on regulators and industry
Apr 1, 2007
By:
Jill Wechsler
The challenge will be to design a system that is flexible, yet appropriate, for the broad range of biological products and the varying quality control capabilities of different manufacturers.
|
New safety programs and the Critical Path Initiative aim to establish standards and policies for developing less risky medical products
Mar 1, 2007
By:
Jill Wechsler
An underlying theme of FDA's drug safety program is that new discoveries in biomedical science can detect risk issues earlier in clinical development.
|
Feb 23, 2007
By:
Jill Wechsler
The Bush administration's spending plan for 2008 treats the US Food and Drug Administration (Rockville, MD, www.fda.org) fairly well, considering the cuts directed at Medicare, Medicaid, and children's health programs and flat funding for the National Institutes of Health (NIH).
|
Manufacturers look to modern manufacturing systems and risk management to reduce costs and oversight
Feb 1, 2007
By:
Jill Wechsler
A series of ICH guidances are encouraging industry to adopt quality-based approaches for achieving the "desired state" of drug and biotech manufacturing: more efficient and flexible operations that can reliably produce high quality therapies with less regulatory oversight.
|
The need to reauthorize PDUFA will focus attention on product safety, prices, and a host of regulatory issues
Jan 1, 2007
By:
Jill Wechsler
FDA is encouraging broader use of pharmacogenomic data by offering manufacturers early informal advice.
|
|
