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Results: 1-10 of 354

FDA issues guidance on acceptance of foreign clinical studies not conducted under IND

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 15 2012

The Food and Drug Administration (FDA) has issued guidance titled “Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions.”

Takeda acquires access to Envoy’s CNS drug pipeline and bacTRAP technology

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

Takeda America Holdings, Inc. has reportedly acquired Envoy Therapeutics, Inc. in a deal worth $140 million, including an up-front payment and progressdependent milestone payments

Biotech secures $5.3 million for immunosuppressant drug research

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 18 2013

San Francisco-based startup, Nurix, Inc., which reportedly develops T-cellspecific immunosuppressants used to treat autoimmune diseases such as

FDA publishes final rule on investigational new drug applications, issues draft guidance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

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

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

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