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Chemistry World
February 3, 2012
Rebecca Trager
Whistleblowers accuse FDA of spying, persecution The US Food and Drug Administration is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2007
Patrick Clinton
From the Editor: Taking It Outside FDA Commissioner Andy von Eschenbach said something pretty reasonable, and in return received a blistering, menacing letter from Senator Charles Grassley -- a letter that showed yet again that Grassley just doesn't understand what he's destroying in his campaign against FDA. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2006
Jill Wechsler
Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf? mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2010
Jill Wechsler
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2011
Jill Wechsler
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2006
George Koroneos
Pharm Exec Q&A: Inside View The Union of Concerned Scientists made revelations about the FDA's own scientific culture. Here, Francesca Grifo, director of scientific integrity program at UCS, talks about the findings. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2006
Jill Wechsler
Pharm Exec Q&A: A Soft Spot for Whistleblowers FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive interview, he explains where the agency goes wrong and what he would do to fix it. mark for My Articles similar articles
National Defense
February 2007
Corrigan & Hickey
Contractors Should Get Ready for Scrutiny Federal contractors must be prepared for the change in political and business climate in Congress. Companies can minimize risks by assessing political dangers and self-assessing ethics and compliance programs. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2009
Jill Wechsler
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? mark for My Articles similar articles
Food Engineering
June 4, 2007
Congress to beef up inspection activities With one food recall after another making headlines, Congress appears intent on beefing up federal government food inspection activities. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2005
Jill Wechsler
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. mark for My Articles similar articles
Geotimes
March 2005
Emily Lehr Wallace
Inside Baseball Rules Congress Knowing the ins and outs of committee jurisdictions and chairmanships is knowledge that can give scientists power in promoting their interests. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2005
Jill Wechsler
Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment. mark for My Articles similar articles
Food Engineering
March 2, 2009
FDA Still Under Fire for Peanut Butter Crisis A key member of the US Senate is losing patience with the FDA over food safety issues. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2009
Jill Wechsler
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2011
Jill Wechsler
Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight. mark for My Articles similar articles
Reason
April 2008
Ronald Bailey
Medical Speech As a 1997 law expires, the FDA is mulling a plan allowing companies to disseminate unabridged reprints of "truthful and non-misleading" medical journal articles describing "off-label" uses of approved medications to physicians. mark for My Articles similar articles
The Motley Fool
January 28, 2005
Karl Thiel
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. mark for My Articles similar articles
Food Engineering
January 1, 2009
Regulatory Watch: Improved FDA plan for food protection Under increasing criticism for its oversight of the nation's food supply, FDA issued a plan to better protect food from accidental and intentional contamination. mark for My Articles similar articles
Chemistry World
March 31, 2015
Matthew Gunther
US Chemical Safety Board chairman resigns The chairman of the US Chemical Safety Board has resigned following allegations of mismanagement, along with accusations that the board has mistreated whistleblowers. mark for My Articles similar articles
Food Processing
September 2010
Diane Toops
Congress Scrambles to Pass Food Safety Legislation As Congress has argued over health care reform, financial reform, two wars, a mortgage crisis and unemployment, amending the U.S. food safety system was put on the back burner. mark for My Articles similar articles
The Motley Fool
June 29, 2010
Brian Orelli
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. mark for My Articles similar articles
CFO
March 1, 2007
Kate O'Sullivan
Capitol Blending Democratic control of Congress probably won't roil the M&A waters -- much. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2011
Jill Wechsler
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2006
Jill Wechsler
Washington Report: The New Agenda Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda with drug pricing and access high on the list. mark for My Articles similar articles
Searcher
March 2007
Mary Alice Baish
Librarians as Change Agents: How You Can Help Influence Public Policy in the 110th Congress Key library issues for the 110th Congress. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2008
Jill Wechsler
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2007
McCook & Daniels
Making the Switch More companies are using Rx-to-OTC switches to extend a brand's life cycle. Prilosec did it. Here, experts dish on how you can do it too. mark for My Articles similar articles
The Motley Fool
September 27, 2007
Brian Lawler
FDA Repeats Itself With Cephalon's Fentora In the wake of a letter from Cephalon to health-care practitioners, the FDA has issued a press release and a public health advisory of the dangers of misusing the company's pain drug Fentora. Investors, take note. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2011
Jill Wechsler
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. mark for My Articles similar articles
The Motley Fool
September 18, 2007
Brian Orelli
PDUFA Reauthorization: Almost There Much to the applause of drug makers and those who invest in them, the Prescription Drug User Fee Act reauthorization looks like it could come out of a Congressional conference committee as early as this week. mark for My Articles similar articles
CIO
March 15, 2006
Allan Holmes
Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market. mark for My Articles similar articles
Pharmaceutical Executive
July 3, 2007
Louis A. Morris
Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way. mark for My Articles similar articles
Chemistry World
November 2, 2011
Rebecca Trager
Escalating Drug Dearth Spooks White House Manufacturing problems are the principal reason for the rapid growth in drug shortages. mark for My Articles similar articles
Food Engineering
January 6, 2008
Regulatory Watch Push for larger FDA food safety budget... Study urged on food from cloned animal... mark for My Articles similar articles
Geotimes
January 2005
Emily Lehr Wallace
Stacking Up the New Congress Whether the new members of Congress will end up on science committees remains to be seen, but regardless, they will be voting on important science policy issues once they come to the floor. mark for My Articles similar articles
Chemistry World
November 21, 2014
Rebecca Trager
Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2013
Jill Wechsler
Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year. mark for My Articles similar articles
Food Processing
January 2005
David Joy
Regulatory Issues: The FDA agenda for 2005 As in the past, the FDA has a full agenda of food regulatory matters in 2005. So it's not good that the FDA's scientists are demoralized and the agency stands accused of being too friendly with a regulated industry. mark for My Articles similar articles
BusinessWeek
November 20, 2006
Dunham & Javers
The Politics Of Change As power shifts on Capitol Hill, business faces a new reality mark for My Articles similar articles
BusinessWeek
May 21, 2007
John Carey
A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it? mark for My Articles similar articles
Chemistry World
January 9, 2015
Rebecca Trager
US poised to approve its first 'biosimilar' drug A key committee of the US Food and Drug Administration has voted in favor of licensing a copycat version of a biological drug. If approved, Sandoz's Zarxio (filgrastim) would be the first 'biosimilar' drug available in the US. mark for My Articles similar articles
Managed Care
June 2002
Oncologists: FDA needs to speed up approval of cancer-fighting drugs A Competitive Enterprise Institute survey of cancer specialists found that almost 8 of 10 oncologists think the FDA's approval process has "hurt their ability, at least once in their medical careers, to treat patients with the best possible care." mark for My Articles similar articles
Reason
Aug/Sep 2009
Jacob Sullum
Cigarette Gag: Smokes and speech In April a bill was passed that includes a provision barring manufacturers from making any statement directed to consumers through the media that would reasonably be expected to result in consumers believing that the product is regulated and endorsed by the FDA mark for My Articles similar articles
Geotimes
May 2004
Kendy & Vranes
Breaking Down the Barriers: A Two-Part Series, Part II Part two in a series on how to effectively lobby your members of Congress. mark for My Articles similar articles
BusinessWeek
December 13, 2004
John Carey
How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs. mark for My Articles similar articles
BusinessWeek
February 4, 2010
Robert Schmidt
Darrell Issa, Tim Geithner's Tormentor The California Republican won't rest until Treasury and the Fed tell all about their roles in bailing out Wall Street firms. mark for My Articles similar articles
The Motley Fool
March 8, 2010
Brian Orelli
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. mark for My Articles similar articles
The Motley Fool
December 31, 2007
Brian Lawler
Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2012
Jill Wechsler
Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives. mark for My Articles similar articles