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Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
Pharmaceutical Executive August 1, 2014 Jill Wechsler	Social Media Struggles Continue Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world.
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.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
Pharmaceutical Executive January 1, 2013 Jill Wechsler	Transformation to Characterize 2013 FDA policies will reshape drug development, while pressure to cut healthcare spending may alter drug coverage and pricing.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
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 January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
Pharmaceutical Executive October 1, 2012 Jill Wechsler	Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny.
Pharmaceutical Executive April 1, 2012 Jill Wechsler	Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors.
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.
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.
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?
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 November 1, 2011 Jill Wechsler	The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices.
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.
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, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
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.
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 May 1, 2007 Kevin A. Schulman	Kid Tested, Government Approved? Critics claim pharma is too richly rewarded for studying drugs in children. Now, several legislative proposals are on the table that just might change that.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
Pharmaceutical Executive July 1, 2014 Jill Wechsler	Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.
Pharmaceutical Executive February 1, 2014 Longacre et al.	Social Media: Have We Reached The Tipping Point? For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites. This month FDA released its draft guidance on the use of "Interactive Promotional Media."
Pharmaceutical Executive June 1, 2014 dos Santos & Leskin	Social Media and the In-House Counsel Social media poses a regulatory and litigation maze that must be carefully navigated by pharmaceutical companies.
Pharmaceutical Executive November 1, 2006 Jill Wechsler	Washington Report: Waiting for Advice Companies are increasingly turning to the Division of Drug Marketing, Advertising and Communication (DDMAC) for opinions on ad materials. That's a good thing. What's bad is that DDMAC has slowed to a crawl.
Pharmaceutical Executive July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
Pharmaceutical Executive January 1, 2006 Jill Wechsler	Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
Pharmaceutical Executive February 1, 2006 Bryan Luce	Back Page: Taking Hold of the Wheel Healthcare decision makers do not consistently consider drugs' value. FDA needs to be pressured to change its stance on communicating economic evidence.
Pharmaceutical Executive February 1, 2013 Jill Wechsler	Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.
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.
Pharmaceutical Executive October 1, 2006 Jill Wechsler	Washington Report: After Plan B: Out of the Quagmire, into the Data The morning-after pill goes OTC, with some special requirements. But is FDA's drug information system up to the task of tracking how it is used?
Pharmaceutical Executive March 1, 2006 Jill Wechsler	Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too.
Pharmaceutical Executive May 1, 2007 Jill Wechsler	Washington Report: Pathways for Proteins The push is on to establish an approval pathway for generic versions of biotech therapies. Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
Pharmaceutical Executive July 1, 2013 Jill Wechsler	Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad.
American Family Physician December 1, 2000 William M. Rados	Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities...
Pharmaceutical Executive December 1, 2013	FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system.
Pharmaceutical Executive February 1, 2012 Jennifer Ringler	Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.
Pharmaceutical Executive April 1, 2011	Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access.
Pharmaceutical Executive February 1, 2006 Jill Wechsler	Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
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 August 1, 2008 Jill Wechsler	Can Sentinel Save Drug Development? FDA's new sentinel system shows the pendulum swing toward safety won't swing back anytime soon.