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Topic: U.S. Food and Drug Administration

Steroid linked to last year’s meningitis outbreak may be tainted

Steroid linked to last year’s meningitis outbreak may be tainted

May 24, 2013 2:38 pm by | 0 Comments

(Updates with type of contamination, details, background)May 24 (Reuters) - The U.S. Food and Drug Administration said on Friday it has received seven reports of negative reactions by patients who ... Read more
Johnson & Johnson plans to submit 10 new products for approval by 2017

Johnson & Johnson plans to submit 10 new products for approval by 2017

May 23, 2013 7:56 am by | 0 Comments

May 23 (Reuters) - Johnson & Johnson said on Thursday that it plans to submit more than 10 new products for regulatory approval by 2017, including drugs to treat hepatitis ... Read more
FDA panel backs a new sleep drug suvorexant at lower dose

FDA panel backs a new sleep drug suvorexant at lower dose

May 23, 2013 6:55 am by | 0 Comments

An advisory panel to the Food & Drug Administration has recommended approval of a new sleep drug that targets the brain's wakefulness centers, but suggested the agency should consider a ... Read more
It’s unanimous: U.S. Senate committee approves drug compounding bill

It’s unanimous: U.S. Senate committee approves drug compounding bill

May 22, 2013 6:58 pm by | 0 Comments

NEW YORK (Reuters) - A U.S. Senate committee on Wednesday unanimously approved legislation that would increase federal oversight for companies that compound and sell sterile drugs across state lines.The proposed ... Read more
Merck’s insomnia drug deemed safe at low dose, but not at higher

Merck’s insomnia drug deemed safe at low dose, but not at higher

May 22, 2013 4:14 pm by | 0 Comments

WASHINGTON (Reuters) - Merck & Co's experimental insomnia drug is safe and effective at the lower of two doses studied but not at the higher, a panel of medical experts ... Read more
After tough times last year, Peregrine Pharma reaches agreement with FDA on late-stage trial for lung cancer drug

After tough times last year, Peregrine Pharma reaches agreement with FDA on late-stage trial for lung cancer drug

May 20, 2013 9:40 am by | 0 Comments

(Reuters) - Peregrine Pharmaceuticals said it reached an agreement with the U.S. Food and Drug Administration on the design of a late-stage trial for its experimental lung cancer drug.The late-stage ... Read more
J&J’s wins ulcerative colitis indication for Simponi

J&J’s wins ulcerative colitis indication for Simponi

May 15, 2013 5:55 pm by | 0 Comments

(Reuters) - The Food and Drug Administration has approved Johnson & Johnson's drug Simponi for patients with moderate to severe ulcerative colitis, an inflammatory disease affecting the colon.Simponi is already ... Read more
For-profit dialysis centers continued to use anemia drug after black box warning

For-profit dialysis centers continued to use anemia drug after black box warning

May 15, 2013 3:40 pm by | 0 Comments

NEW YORK (Reuters Health) - Despite a strong warning from U.S. regulators in 2007, for-profit dialysis centers still gave their kidney failure patients more of a certain anemia drug than ... Read more
What’s behind the FDA’s push for more patient engagement (hint: it’s not that everyone else is doing it)

What’s behind the FDA’s push for more patient engagement (hint: it’s not that everyone else is doing it)

May 13, 2013 11:04 am by | 0 Comments

Lately, the U.S. Food and Drug Administration seems to be doing a bit of re-branding: A new Patient Network site is anchoring a push for more patient engagement in the ... Read more
Is an Office of mHealth the best thing about the bill creating an Office of mHealth?

Is an Office of mHealth the best thing about the bill creating an Office of mHealth?

May 12, 2013 9:30 am by | 1 Comments

Version 2.0 of a plan to create an Office of mHealth in the U.S. Food and Drug Administration should be out soon. The office of U.S. Rep. Mike Honda, Silicon ... Read more
FDA allows sales of generic Opana painkiller to continue

FDA allows sales of generic Opana painkiller to continue

May 11, 2013 4:57 am by | 0 Comments

Federal regulators said Friday that they would continue to allow sales of generic Opana, a narcotic painkiller similar to OxyContin, even though the pills are prone to abuse.Like OxyContin, Opana ... Read more
FDA approves Glaxo/Theravance drug for COPD lung disease

FDA approves Glaxo/Theravance drug for COPD lung disease

May 10, 2013 11:35 am by | 0 Comments

(Reuters) - The Food and Drug Administration has approved a new drug to treat chronic obstructive pulmonary disease, a condition often associated with smoking that can include emphysema, chronic bronchitis, ... Read more
Judge criticizes FDA move on Plan B, agency warns of precedent

Judge criticizes FDA move on Plan B, agency warns of precedent

May 7, 2013 4:20 pm by | 0 Comments

NEW YORK (Reuters) - A federal judge criticized the Food and Drug Administration over its refusal to make emergency contraception available to girls of all ages without a prescription, saying ... Read more
FDA strengthens warnings on tanning beds to reduce cancer risk

FDA strengthens warnings on tanning beds to reduce cancer risk

May 6, 2013 2:33 pm by | 0 Comments

Washington (Reuters) - Tanning beds and sunlamps will be required to carry stronger warning labels under new regulations proposed by the U.S. Food and Drug Administration, which is also recommending ... Read more
FDA warns shorter name of new Roche cancer drug may cause confusion

FDA warns shorter name of new Roche cancer drug may cause confusion

May 6, 2013 11:01 am by | 0 Comments

(Reuters) - The U.S. health regulator warned on Monday that using a shorter name for Roche's new breast cancer drug Kadcyla may lead to the treatment being confused with an ... Read more