A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
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A mass poisoning of 105 patients treated with an untested medication spurred Congress to empower the US Food and Drug Administration to monitor drug safety.
From now on, US physicians and researchers will have to get approval from the FDA before they can perform a stool transplant.
After numerous high-profile safety scares, clinicians and regulators push to fix critical weaknesses in the FDA’s monitoring system for approved drugs.
Two experts propose replacing Phase 3 trials with smaller, faster alternatives and post-market surveillance to invigorate the pharmaceutical industry.
A retinal prosthesis, already available in Europe, can restore partial sight to people with a genetic disorder that causes blindness.
A company offering experimental stem-cell treatments will carry out its procedures in Mexico after the FDA warned that it would need approval to operate in the U.S.
Patient safety is paramount in regulating new stem cell treatments.
The US Food and Drug Administration approves the first flu vaccine made from recombinant proteins rather than a weakened virus.
After undergoing untested cosmetic surgery that uses stem cells to rejuvenate skin, a woman grew bone fragments in the flesh around one of her eyes.
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