OR WAIT null SECS
September 01, 2005
New Guidance May Speed Generic Approvals
May 27, 2005
New Excipient Guidance Doesn?t Fill Regulatory Gap
March 31, 2005
FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data
February 24, 2005
CBER Draft Guidance for Spore-Formers and Plasmid Vaccines
May 01, 2004
FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.
May 01, 2003
The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.
On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.
March 01, 2003
As the US Food and Drug Administration (FDA) strives to streamline its regulatory process for bringing new drugs to market (see sidebar "Manufacturing data key to spurring drug development"), efforts to ensure the quality, safety and efficacy of dietary supplements and herbal medicines are gaining more attention.
February 01, 2002
Participants at a Pharmaceutical Research and Manufacturers of America workshop share their views about the acceptable analytical practices of conducting forced degradation studies.