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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. |
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. |
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? |
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 |
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 |
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. |
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. |
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. |
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? |
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. |
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. |
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. |
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. |
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. |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
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. |
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. |
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. |
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. |
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. |
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. |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
CFO March 1, 2007 Kate O'Sullivan |
Capitol Blending Democratic control of Congress probably won't roil the M&A waters -- much. |
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. |
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. |
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. |
Pharmaceutical Executive September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. |
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. |
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. |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
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. |
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. |
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. |
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. |
Food Engineering January 6, 2008 |
Regulatory Watch Push for larger FDA food safety budget... Study urged on food from cloned animal... |
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. |
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 |
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. |
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. |
BusinessWeek November 20, 2006 Dunham & Javers |
The Politics Of Change As power shifts on Capitol Hill, business faces a new reality |
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? |
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. |
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." |
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 |
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. |
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. |
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. |
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. |
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. |
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. |