Regulatory News

  • FDA unit launches workshops to encourage orphan-drug applications

    The FDA's Office of Orphan Products Development is hosting workshops to encourage research into treatments for rare diseases among drug and biotech companies, academic institutes as well as patient advocates. The first seminar was held last month and resulted in 14 submissions for orphan-drug status out of 29 potential sponsors, but Timothy Coté, director of the division, said he hopes to gather more applications during the second workshop in August.

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  • Allergan obtains FDA approval for wider use of Botox

    Allergan received FDA approval to market Botox as a treatment for elbow, wrist and finger spasticity. The agency warned that the muscle relaxant should not be used for fixed contracture, upper limb muscles or leg spasms.

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  • FDA's Hamburg defends opposition to drug reimportation

    FDA Commissioner Margaret Hamburg explained her opposition to drug reimportation in a Senate panel hearing, saying that allowing medicines that might have a different formulation to enter the country would create logistical issues that could compromise product safety. Hamburg also said the agency is still evaluating whether it can handle the safety regulation of reimported pharmaceuticals, but she did not specify a deadline for the review.

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  • InterMune's pirfenidone gains FDA panel's support for approval

    A panel of FDA advisers endorsed the approval of pirfenidone, InterMune's drug for idiopathic pulmonary fibrosis, but also recommended follow-up studies on the treatment's ability to extend patient survival. The FDA is expected to decide on the drug by May 4.

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  • JAMA report: FDA should look at comparative-effectiveness studies

    Less than 20% of comparative-effectiveness studies address fundamental issues, such as how a medicine can be used more effectively, according to a report in the Journal of the American Medical Association. The lead researchers called on the FDA to consider requiring studies that compare the cost and safety of candidate drugs and non-pharmacological therapies.

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  • FDA approves facility for production of Cell Therapeutics' pixantrone

    The FDA cleared Cell Therapeutics' request to manufacture cancer drug pixantrone at NerPharMa, a facility owned by Nerviano Medical Sciences in Italy. The agency is expected to issue an approval decision on the treatment by April 23.

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