Sidney Wolfe

Type: Person
Name: Sidney Wolfe
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Lipocine Is A Compelling Investment Opportunity With Impending Phase 3 Data

Summary Lipocine is a specialty pharmaceutical company with a novel drug delivery technology for application in men’s and women’s health. The company’s lead product, LPCN 1021, is an oral testosterone replacement therapy (TRT) in a Phase 3 pivotal trial ... [Published Seeking Alpha - Aug 19 2014]
First reported Aug 15 2014 - Updated Aug 15 2014 - 1 reports

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe

In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs (read ... [Published Pharma Marketing Blog - Aug 15 2014]
First reported Aug 14 2014 - Updated Aug 14 2014 - 1 reports

Safety concerns about new drugs revealed

By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA (Boston)-What's safer: a newly approved drug or one that has been on the market much longer? Newer drugs have a one in three chance of acquiring a black box warning or being withdrawn ... [Published Pharmacy Choice - Aug 14 2014]
First reported Aug 07 2014 - Updated Aug 08 2014 - 1 reports

Study: Speedy FDA Approvals Could Jeopardize Safety

Drugs launched after Congress passed legislation to accelerate the approval process are more likely to be given safety warnings or pulled from the market altogether, according to a new study critical of the FDA’s current review process.Patient advocate ... [Published FDA News - Aug 07 2014]
First reported Aug 08 2014 - Updated Aug 08 2014 - 1 reports

Safety Concerns About New Drugs

The authors of a study published in the August 2014 issue of Health Affairs contend that when the FDA approval process for medications changed in 1992 with the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug ... [Published ThirdAge - Aug 08 2014]
First reported Aug 06 2014 - Updated Aug 06 2014 - 1 reports

Safety fears over faster US drug approvals

Drugs approved in the US since 1992, when user fees were introduced to expedite their approvals, have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of approval, says new research. The study, ... [Published Pharma Times - Aug 06 2014]
First reported Aug 05 2014 - Updated Aug 06 2014 - 3 reports

Have faster drug approvals led to more dangerous drugs?

New medications that get the green light from the US Food and Drug Administration for safety and efficacy have more than a one in four likelihood of getting a black box warning or being withdrawn from the market within 25 years of their approval. That ... [Published Boston Globe - Aug 06 2014]
First reported Aug 04 2014 - Updated Aug 04 2014 - 1 reports

Safety concerns about new drugs revealed

What's safer: a newly approved drug or one that has been on the market much longer? Newer drugs have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of their approval, according to a new study ... [Published Medical Xpress - Aug 04 2014]
First reported Jun 30 2014 - Updated Jun 30 2014 - 1 reports

Honor Roll: Madison Avenue Elementary School, Fourth nine-weeks, 2013-14

Madison Avenue Elementary SchoolRiverside Local SchoolsFourth Nine-week grading period 2013-2014A-TeamThird Grade A-Team :Andrew Baczek, Max Borris, Caden Elersich, Isabella Frohnapfel,  Payton Jasinski, Chase Johnson, Hailie Kotrlik, Kylie Lanning, Braden ... [Published News-Herald - Jun 30 2014]
First reported May 01 2014 - Updated May 01 2014 - 1 reports

Should Doctors Play Executioner?

After the botched execution in Oklahoma, Room For Debate wrestles with question. Neil J. Farber examines opinion within the medical community: In the survey in 2000, 1,000 physicians in the United States were asked whether they condoned colleagues’ ... [Published The Daily Dish | By Andrew Sullivan - May 01 2014]
First reported Apr 18 2014 - Updated Apr 18 2014 - 1 reports

LawyersandSettlements.com Interviews Two Experts Regarding...

The debate over the extent to which testosterone supplements may contribute to heart attack has medical experts weighing in with contradictory opinions on the issue. To understand the opposing views, and the background for recent testosterone lawsuits, ... [Published PRWeb - Apr 18 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 1 reports

Honor Roll: Madison Avenue Elementary School, Third nine-week period, 2013-2014

Madison Avenue Elementary SchoolRiverside Local Schools, Painesville TownshipA-TeamThird grade: Andrew Baczek, Samanta Flores, Chase Johnson, Cameron Simpson, Emily White, Max Borris, Isabella Frohnapfel, Hailie Kotrlik, Kyle Sisa, Emma Wittie, Hayley ... [Published News-Herald - Apr 15 2014]

Quotes

"the fda's resources for reviewing drugs have increased dramatically since the passage of pdufa, amounting to $760 million this fiscal year from pharmaceutical companies, about two-thirds of the agency's drug review budget" said study co-author Sidney Wolfe, MD, founder of Public Citizen's Health Research Group and author of "Worst Pills, Best Pills...
Frank opts to prescribe older drugs when they are available. Wolfe said that "there's no reason to prescribe a drug that is not a break-through drug." He recommends not taking a drug until it's been on the market for at least seven years

More Content

All (17) | News (14) | Reports (0) | Blogs (3) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
sort by: Date | Relevance
Lipocine Is A Compelling Investment Opportunity... [Published Seeking Alpha - Aug 19 2014]
FDA's "Off-Label Risk Reduction" Approach to Re... [Published Pharma Marketing Blog - Aug 15 2014]
Safety concerns about new drugs revealed [Published Pharmacy Choice - Aug 14 2014]
Safety Concerns About New Drugs [Published ThirdAge - Aug 08 2014]
Study: Speedy FDA Approvals Could Jeopardize Sa... [Published FDA News - Aug 07 2014]
Safety fears over faster US drug approvals [Published Pharma Times - Aug 06 2014]
Have faster drug approvals led to more dangerou... [Published Boston Globe - Aug 06 2014]
Fast-Tracking Drugs Through the FDA Has Side Ef... [Published Phoenixville Phoenix - Aug 05 2014]
Newly-approved drugs have one in three chance o... [Published Pharma Letter - Aug 05 2014]
Safety concerns about new drugs revealed [Published Medical Xpress - Aug 04 2014]
Honor Roll: Madison Avenue Elementary School, F... [Published News-Herald - Jun 30 2014]
Should Doctors Play Executioner? [Published The Daily Dish | By Andrew Sullivan - May 01 2014]
LawyersandSettlements.com Interviews Two Expert... [Published PRWeb - Apr 18 2014]
Honor Roll: Madison Avenue Elementary School, T... [Published News-Herald - Apr 15 2014]
Public Citizen Petitions FDA for a Black Box Wa... [Published PharmaGossip - Feb 25 2014]
Honor Roll: Madison Avenue Elementary School, s... [Published News-Herald - Jan 30 2014]
Honor Roll: Madison Avenue Elementary School, F... [Published News-Herald - Dec 10 2013]
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sort by: Date | Relevance
FDA's "Off-Label Risk Reduction" Approach to Re... [Published Pharma Marketing Blog - Aug 15 2014]
In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs (read ...
Should Doctors Play Executioner? [Published The Daily Dish | By Andrew Sullivan - May 01 2014]
After the botched execution in Oklahoma, Room For Debate wrestles with question. Neil J. Farber examines opinion within the medical community: In the survey in 2000, 1,000 physicians in the United States were asked whether they condoned colleagues’ ...
Public Citizen Petitions FDA for a Black Box Wa... [Published PharmaGossip - Feb 25 2014]
WASHINGTON - February 25 - Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing ...
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