Proposed FDA Rules on Painkillers in U.S. Rile Cancer Community

Proposed FDA rules on painkillers in U.S. Rile cancer community.

Undertreatment of cancer pain remains a substantial problem, according to a new survey conducted by the American Cancer Society. Published in May, the survey found that 65% of interviewees had moderate or severe pain. Now, an initiative from the U.S. Food and Drug Administration could make it even more diffi cult for cancer patients to get adequate pain relief by limiting access to opioids, acc...

Comments on Proposed Remote Search Rules

Thank you for the opportunity to submit comments on the proposed amendments to the Preliminary Draft of Proposed Amendments to the Federal Rules of Appellate, Bankruptcy, Civil, and Criminal Procedure1 rules for remote search. We are focusing our comments on the suggested changes to Rule 41, and in particular to the discussion of remote search. While we do not oppose the concept in principle, i...

Does the FDA Owe Us an Explanation?

The approval process for new medications sometimes appears to require pharmacokinetic data in some circumstances and clinical trial data in others. This editorial calls for more clarity and transparency in the process and uses three examples to raise the issue.

Poisoning in children 2: painkillers.

Biosimilars: part 1: proposed regulatory criteria for FDA approval.

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.