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Results: 11-20 of 48

Generic drug user fee program: coming soon?

  • Alston & Bird LLP
  • -
  • USA
  • -
  • August 31 2010

On September 17, FDA will hold a public meeting to begin gathering stakeholder input on the implementation of a generic drug user fee program

Use of a centralized institutional review board

  • Alston & Bird LLP
  • -
  • USA
  • -
  • August 31 2010

On April 30, 2010, the Office for Human Research Protections (OHRP) published a letter responding to a medical center's question regarding the use of a central institutional review board (IRB

Agencies outline preventive care coverage requirements under PPACA

  • Alston & Bird LLP
  • -
  • USA
  • -
  • July 27 2010

The Departments of Health and Human Services (HHS), Treasury and Labor (collectively the "Agencies") issued interim final regulations ("Regulations") on July 14, 2010, regarding the new preventive care coverage requirements set forth in new Public Health Service Act (PHSA) Section 2713, as added by the Patient Protection and Affordable Care Act (PPACA

Window closing for comments on FDA transparency proposals

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

The public comment period soon will end on 21 draft proposals FDA issued regarding its policy on the public disclosure of information in its possession (as weighed against the public interest in maintaining confidentiality of information

Policy & Hill update

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

Since the passage of health care reform, attention within HHS has turned to implementation

FDA examining laboratory developed tests (LDTs)

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

In a long-awaited "next step", the FDA announced in the Federal Register that it has scheduled a meeting to be held on July 19-20, 2010 to discuss the regulation of LDTs, a class of in vitro diagnostics that are manufactured (i.e., developed, validated and offered) within a single laboratory against which FDA has exercised its enforcement discretion and not applied its regulations

OIG issues updated recommendations on FDA oversight of foreign clinical trials

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

In September 2001, the Office of Inspector General (OIG) issued a report on "The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects" that detailed the dramatic increase in foreign clinical trials of drug products

FDA revisiting REMS draft guidance and overall policy in upcoming public meeting

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

The agency recently announced an upcoming, two-day public meeting July 27-28 to solicit stakeholder feedback on the issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biologics

FDA proposes standards for major statements in DTC advertising

  • Alston & Bird LLP
  • -
  • USA
  • -
  • April 16 2010

FDA recently issued a proposed rule to implement the provision of the Food and Drug Administration Amendments Act (FDAAA) of 2007 requiring that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous and neutral manner

Periods of note

  • Alston & Bird LLP
  • -
  • USA
  • -
  • April 16 2010

Following its recent public meeting, the Food Safety and Inspection Service (FSIS) is seeking comments on ways to improve Agency procedures for identifying product that may be positive for E. coli O157:H7