FDAnews Drug Daily Bulletin
June 5, 2012 | Vol. 9 No. 110
Clearly feeling the sting of the chromium-contaminated drug capsule scandal, China’s State Food and Drug Administration (SFDA) is proposing to draw up a “blacklist” of executives that oversee pharmaceutical companies in China found to produce substandard or counterfeit drugs.
Beginning Sept. 1, new drug applications to the Saudi Food and Drug Administration (SFDA) must include an electronically submitted non-electronic common technical document (CTD).
Drugmakers could bring breast cancer treatments to market a decade earlier with new FDA guidance on trial designs for evaluating pathologic complete response (pCR) to support accelerated approval of drugs to treat high-risk, early-stage breast cancer.
Pharmacists are urging Congress to abandon plans to more heavily restrict hydrocodone, a popular opioid painkiller, arguing that such a move would cut off legitimate pain patients from needed medication and impose harsh burdens on pharmacies.
A Greek exit from the euro would further depress drug prices throughout Europe, creating an additional dilemma for manufacturers already wrestling with how to keep supplies flowing as Greek health-care funds dry up.
Patients with metastatic breast cancer did just as well — and maybe better — with paclitaxel-based chemotherapy compared with two newer, more expensive agents, results of a randomized trial showed.
Opioids can be a very effective pain treatment, but whether they work well at treating chronic noncancer-related pain long term is unclear and sorely needs more study, pain experts agreed.
It can be painful and embarrassing for men: a disease that causes a curvature of the penis that makes intercourse difficult or impossible.
Britain faces $46 billion bill to clean up rivers, streams and drinking water supplies contaminated by synthetic hormones from contraceptive pills.
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