King & Spalding Expands Government Affairs Expertise with Strategic Hires
In a significant move reflecting its continued focus on regulatory and government affairs, King & Spalding has announced the addition…
fda
Pharmaceutical Giants Challenge Zantac Cancer Claims in Delaware Court
In a crucial legal battle, pharmaceutical companies, including GSK, Pfizer, and others, seek to convince a Delaware judge that the…
FDA Preliminary Review Finds No Evidence of Suicidal Thoughts Linked to Weight-Loss Drugs
In a recent development, the U.S. Food and Drug Administration (FDA) reported that its preliminary review did not uncover any…
Marijuana May Be Legal in Some States but Still Not Federally
Summary: The Drug Enforcement Administration declined the proposal to remove or at least loosen the restrictions on marijuana for medical…
Federal Government Now Regulating Vaping Industry
Summary: The federal government will now regulate the e-cigarette industry as harshly as it regulates big tobacco. Dora the Explorer…
U.S. Supreme Court Rules 5-4 in Favor of Death Penalty
Summary: Although midazolam has not been approved by the FDA for its usage in lethal injections, it is the only…
Hogan Lovells Welcomes Heidi Gertner to Pharmaceutical and Biotech Group
Summary: The law firm of Hogan Lovells announced on Monday morning that Heidi Gertner has joined the firm from the Food…
FDA Tells How to Tweet About Prescription Drugs and Devices
The USFDA has published draft guidance (scroll down to read the draft) telling Pharma companies how to tweet about their…
FDA Inquiring: Unreported Injuries Due to Robotic Surgeries
In 2012, the FDA received detrimental reports of injuries, death and malfunctions associated with robotic surgery procedures…
FDA Ignores Medical Board and Approves Painkiller with Potential of Abuse
The FDA has totally ignored the 11-2 disapproval of its medical advisory board and proceeded to approve Zohydro, a drug,…
How Many Rodent Hairs Allowed in Your Paprika by the FDA?
The recently published Defect Levels Handbook by the FDA enumerates the levels of defect beyond which it becomes actionable.…
FDA Gives First Approval to Pre-Surgical Breast Cancer Drug
On Monday, the FDA gave its first approval to a pre-surgical breast cancer drug. The drug, Perjeta, manufactured by Roche…