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Results: 1-10 of 12,185

FDA Draft Guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 17 2018

On July 3, 2018, the FDA issued draft guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products. The


FDA Warns of Illegal Online Pharmacies Sending Fake FDA Warning Letters Instead of Medicines to Would Be Customers
  • Keller and Heckman LLP
  • USA
  • July 16 2018

The U.S. Food and Drug Administration is warning consumers about criminals forging FDA Warning Letters to target individuals who tried to purchase


Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
  • Knobbe Martens
  • USA
  • July 16 2018

References were sufficiently accessible to the public to constitute printed publication prior art even if they were not searchable or indexed because


Endo Pharmaceuticals Solutions v. Custopharm Inc.
  • Knobbe Martens
  • USA
  • July 16 2018

A prior art reference does not inherently disclose the elements of a claim limitation if the prior art describes the performance of the elements but


DOJ Announces Revised Opioid Anti-Diversion Policy
  • FisherBroyles LLP
  • USA
  • July 16 2018

Last week, the Department of Justice (DOJ) announced that it had finalized new rules to prevent the diversion of prescription opioids in a move


FDA Issues Proposed Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance
  • Hogan Lovells
  • USA
  • July 13 2018

The Food and Drug Administration (FDA) is proposing to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to


FDA Publishes Proposed Revision to and Extended Compliance Date for Front of Pack Calorie Declaration for Vending Machines
  • Keller and Heckman LLP
  • USA
  • July 13 2018

The Food, Drug, and Cosmetic Act (FDCA) Section 403(q)(5)(H) (located at 21 USC Section 343(q)(5)(H)) requires certain vending machine operators to


Takeaways from FDA ‘Steak-holder’ Meeting on Cell-Cultured Foods
  • Morgan Lewis
  • USA
  • July 13 2018

The Food and Drug Administration (FDA) held a public meeting July 12 on “Foods Produced Using Animal Cell Culture Technology” to give the public an


In the Weeds: Navigating the Shifting Federal Regulation of Medical Marijuana
  • K&L Gates
  • USA
  • July 13 2018

The federal government’s view of medical marijuana is evolving as the U.S. Food and Drug Administration (“FDA” or “Agency”), on June 25, 2018


The FDA Approves Active Ingredient Derived from Marijuana to Treat Epilepsy
  • Knobbe Martens
  • USA
  • July 13 2018

On June 25th, 2018, the U.S. Food and Drug Administration (FDA) approved the drug, Epidiolex, for the treatment of seizures associated with two rare