Standards & Regulations

Aug 02, 2002
Pharmaceutical Technology
In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.
Jul 02, 2002
Pharmaceutical Technology
To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.
Jun 01, 2002
Pharmaceutical Technology
FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.
May 01, 2002
Pharmaceutical Technology
ICH continues its efforts to establish universal drug development standards and testing as pharmaceutical manufacturers press for additional FDA guidance on specifications.
Apr 01, 2002
Pharmaceutical Technology
Proposed funding increases for FDA reflect plans to significantly increase user fees collected from manufacturers under the Presciption Drug User Fee Act.
Mar 01, 2002
Pharmaceutical Technology
FDA wants manufacturers to revise product labeling and packaging and step up adverse-event monitoring to reduce risky product use.
Feb 01, 2002
Pharmaceutical Technology
FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.
Jan 01, 2002
Pharmaceutical Technology
Pharmaceutical companies will face a number of issues and challenges this year that will affect their resources, operations, and the markets they serve.
Dec 02, 2001
Pharmaceutical Technology
Anthrax contamination has put pharmaceutical quality and supply issues on the front page, along with patent and pricing policies.
Nov 02, 2001
Pharmaceutical Technology
Threats of bioterrorism generate new reulatory policies to protect the public against biological warfare.
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