We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 11-20 of 605

FDA publishes final rule on investigational new drug applications, issues draft guidance

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

The Food and Drug Administration (FDA) has issued a final rule that amends its "regulations governing safety reporting requirements for human drug and biological products subject to an investogational new drug application (IND)."

FTC conducts workshop on competition and safety in pet meds industry

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

The U.S. Federal Trade Commission (FTC) conducted a day-long workshop, October 2, 2012, “to examine competition and consumer protection issues in the pet medications industry.”

Stakeholders provide input on FDA review standards for biosimilars

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 18 2010

The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics

French company prevails in dispute with FDA over drug-classification ruling

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements

Consumer-fraud class action filed against 23andme after FDA action

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • December 12 2013

Citing the Food and Drug Administration's (FDA's) November 22, 2013, warning letter, a California resident has filed a putative class action against

FDA challenges classification of stem cell-based bone regeneration product

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 4 2011

The Food and Drug Administration (FDA) has warned Parcell Laboratories that it mischaracterized its stem cell-based bone regeneration product as a human cell, tissue and cellular or tissue-based product, when the product is actually a drug or a biologic and must conform to applicable regulations

Bipartisan bill would curb FDA’s medical apps oversight

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 31 2013

A bipartisan group of U.S representatives has introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (H

Array BioPharma signs oncology agreement with Genentech

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 18 2011

Array BioPharma has reportedly signed an agreement with Genentech, a member of Roche Holding AG, to develop cancer compounds involving each company’s small-molecule Checkpoint kinase 1 (ChK-1) program

Comments sought on Class B medical device registration guidance in Singapore

  • Shook Hardy & Bacon LLP
  • -
  • Singapore
  • -
  • June 21 2012

Singapore’s Health Sciences Authority is requesting stakeholder comments by June 28, 2012, on new guidance pertaining to the registration of Class B medical devices

FDA seizes probiotic products marketed as drugs

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 16 2011

The Food and Drug Administration (FDA) has reportedly seized probiotic products from a Minnesota-based company, alleging that they are being marketed as drugs