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BioWorld - Friday, January 9, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

FTC Dons Sheriff's Badge in Wild West of Social Media

March 14, 2013
By Mari Serebrov
The taming of the Wild West of social media has begun, with the FTC reinforcing its role as sheriff. To keep the peace and help drugmakers and other industries ride through the new digital territories unscathed, the FTC updated its 13-year-old ".com Disclosures" guidance.
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Senate Appropriators Propose Millions More for the FDA

March 13, 2013
By Mari Serebrov
Despite the continuing grip of sequestration, the FDA will breathe easier if a bipartisan Senate appropriations proposal becomes part of a hybrid spending package intended to fund the government for the remainder of fiscal 2013.
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‘Indirect’ Fat Clogging NIH’s Arteries

March 12, 2013
By Mari Serebrov
In the days before the sequester tightened Washington’s belt, the National Institutes of Health (NIH) and several other federal agencies sent up warning shots of just what was at stake. Under the automatic budget cuts intended to put the national deficit on a strict diet, the NIH expected to lose $1.6 billion from its 2013 fiscal budget. If the sequester stayed in place, NIH Director Francis Collins said the agency would give "hundreds and hundreds" fewer grants than it would have awarded otherwise, slowing down important research. Speaking at a news conference, Collins said the NIH was trying to avoid...
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U.S. only days away from syncing its patent rules

March 12, 2013
By Mari Serebrov

U.S. Just Days Away from Syncing its Patent Rules

March 12, 2013
By Mari Serebrov
Beginning next week, the U.S. patent system will be in step with the rest of the world. But to keep pace, the Patent and Trademark Office (PTO) and industry will have to manage a steep learning curve as the nation switches from first-to-invent patent claims to a globally accepted first-to-file system.
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FDA Unveils Plan for Structured Benefit-Risk Assessment

March 8, 2013
By Mari Serebrov
Seeking to lift the veil on its approval process, the FDA released a draft five-year plan describing the steps it's taking to further develop and implement a structured benefit-risk assessment to be used in agency reviews of drugs and biologics.
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Adcoms Recommend Higher Standards for Calcitonin Drugs

March 6, 2013
By Mari Serebrov
Drugmakers with calcitonin salmon products under development for postmenopause osteoporosis (PMO) may have to do a lot more work to get the drugs approved following a joint FDA advisory committee meeting Tuesday.
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Sequester Sword Falling on U.S. Federal Programs

March 4, 2013
By Mari Serebrov
The thin thread suspending Damocles' sword inches from federal budgets snapped Friday as Congress and the president threw up their hands on averting a sequester that will bring across-the-board cuts to most government programs, including those at the FDA and National Institutes of Health.
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FDA, NIH Brace for Sequester Cuts, Public Health Impact

March 4, 2013
By Mari Serebrov
Although they hoped it wouldn't come to this, the FDA and National Institutes of Health (NIH) are preparing for the reality of the sequester sword.
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Ahead of Adcom, the FDA Questions Serada's Efficacy

March 1, 2013
By Mari Serebrov
Depomed Inc.'s Serada could become the first approved nonhormonal therapy for menopausal hot flashes, but its advisory committee debut Monday doesn't look like it's going to be a walk in the park.
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