48 results

• FDA Looks at Reorganizing Its Human Foods Program After Botched Similac Infant Formula Recall

  February 1, 2023

  Irvin Jackson

  The FDA has announced plans to reorganize its Human Foods Program, with a greater focus on nutrition, and coordination with state and local regulators.

• Propecia Side Effects Linked to Increased Risk of Depression: Study

  January 6, 2023

  Irvin Jackson

  A new study links Propecia side effects to an increased risk of depression.

• Nitrosamines Problems Are More Widespread in Drugs Than FDA Anticipated: Report

  November 1, 2022

  Irvin Jackson

  The FDA has been caught off-guard by the number of drugs being recalled for nitrosamine contamination and is likely to update a 2020 guidance to better address the problem according to a recent report.

• GAO Report Calls On FDA To Improve Foreign Inspections

  February 8, 2022

  Martha Garcia

  The GAO has issued a report calling on the FDA to improve foreign drug manufacturing inspections by adding more investigators, conducting surprise inspections, and expanding its translation services.

• FDA System For Approving New Drugs Found Lacking By Study

  September 24, 2021

  Irvin Jackson

  A new study warns that the FDA fails to rely on previous experience in dealing with the approval of drugs with questionable effectiveness, which could erode public trust.

• Lawsuit Seeks FDA Propecia Recall Over Risk of Depression, Erectile Dysfunction and Suicide

  September 14, 2021

  Irvin Jackson

  The FDA faces a lawsuit by a group calling for a Propecia recall, or more stringent label warnings, due to suicide risks linked to the hair loss drug.

• Distrust of FDA Drug Approval Process Leads To Hesitation Prescribing New Meds: Survey

  August 4, 2021

  Russell Maas

  Doctors say they are losing confidence in new drugs approved by the FDA following a number of recent decisions and perceptions of an overly close relationship with the pharmaceutical industry.

• FDA Safety Inspections Falling Further Behind Due To COVID-19 Pandemic, GAO Report Warns

  March 9, 2021

  Irvin Jackson

  While federal regulatory agencies continue to limit travel during the COVID-19 pandemic, a new government watchdog report warns that the...