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Results: 1-10 of 20

Agree to disagree: FDA and customs origin and drug labeling requirements

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • March 7 2013

When merchandise is imported into the United States, there is a slew of information required to be reported to United States Customs and Border

Sequestration: the ripple effect on the life sciences industry

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • March 1 2013

With sequestration scheduled to take effect today, the looming cuts to the U.S. Food and Drug Administration are concerning for the whole of the life

Update: Second Circuit rejects government’s off-label enforcement approach

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • January 24 2013

On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No

Second Circuit throws out conviction for off-label marketing as violating the First Amendment

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • December 17 2012

The recent decision in United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012) dealt a blow to the government's efforts to prosecute off-label

Whistleblower lawsuit against drug maker fails because “off-guideline” marketing does not constitute “off-label” marketing

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • November 27 2012

In welcome news for the pharmaceutical industry, the U.S. District Court for the Eastern District of New York, in United States ex rel. Polansky v. Pfizer, Inc., 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), issued a decision distinguishing between unlawful “off-label” marketing and lawfully marketing a drug for use outside of recommended guidelines

The FDA proposes new rule on unique medical device identification and marking requirements

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • August 2 2012

The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages

New FDA informed consent requirements for applicable clinical trials: practical approaches for implementation

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • March 2 2012

For applicable clinical trials regulated by the U.S. Food and Drug Administration (FDA) that are initiated on or after March 7, 2012, sponsors, investigators and institutional review boards will have to assure compliance with an additional informed consent requirement

CMS’s proposed “Sunshine” regulations: implications for research

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • January 31 2012

On Dec. 19, 2011, the Centers for Medicare & Medicaid Services released a Proposed Rule to implement 6002 of the Patient Protection and Affordable Care Act, commonly referred to as the Physician Payment Sunshine Act

CMS releases proposed rule implementing the physician payment “Sunshine” provisions of the Affordable Care Act

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • January 31 2012

On Dec. 19, 2011, the Centers for Medicare & Medicaid Services released a Proposed Rule to implement 6002 of the Patient Protection and Affordable Care Act, commonly referred to as the Physician Payment Sunshine Act

Misusing misuse: California’s proposed misguidance to juries on the effect of unforeseeable product misuse

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • June 13 2011

California courts have often been at the forefront of expansion of manufacturers’ obligations under products liability law

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