• where experts go to learn about FDA
  • Kalie E. Richardson

    • Does the Drug Shortage White Paper Fall Short?April 9th, 2024

      The U.S. Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States—with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and …

    • GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection ProgramMarch 29th, 2024

      While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. Inspections went down—way down—during the pandemic. In March 2020, FDA temporarily postponed all foreign and domestic and …

    • The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing FacilitiesJuly 5th, 2023

      Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance).  As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the …

    • 2023 IS the Year for OTC Naloxone!March 30th, 2023

      Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent.  I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic …

    • Upcoming OTC Naloxone Joint Advisory Committee Meeting CancelledMarch 2nd, 2023

      As of the morning of March 1, the hotly anticipated Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee originally scheduled for March 20 has been cancelled.  The March 20 Joint Meeting concerned the NDA for naloxone …

    • Is 2023 the Year for OTC Naloxone?February 17th, 2023

      On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.  All …

    • FDA Takes Another Small Step to Increase Naloxone AccessOctober 13th, 2022

      While COVID-19 and monkeypox may be the public health emergencies garnering much of our current attention, we have been in the midst of another declared public health emergency for nearly 5 years: the opioid crisis.  FDA recently issued a Guidance (Exemption and Exclusion From Certain …

    • President Biden Gives the Green Light for Significant Marijuana ReformOctober 10th, 2022

      On October 6, President Joe Biden issued a brief but sweeping three-step statement towards reforming Federal marijuana law.  The president’s first step was a pardon of all prior federal offenses of simple marijuana possession and a direction to the Attorney General to develop an administrative …

    • The Wait is — Almost — Over: The Long-Anticipated Proposed Rule for Drug Wholesale Distributors and 3PLs is Out: Comments Due in 120 DaysFebruary 4th, 2022

      FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”).  The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within …

    • Pharmacy Owner Pleads Guilty to Federal Charges for Illegally Administering COVID-19 Vaccines to Children Under 12September 29th, 2021

      On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 …

    • Is Facebook Ghosting Pharma?September 1st, 2021

      In what appears to be an “about face” in terms of Facebook’s historical wooing of big pharma (are we the only ones that immediately thought, “More Cowbell” when seeing that headline?  You can thank us for that 5 minute rabbit hole later), the social media …

    • Minnesota Proposes to Reduce Opioid Product Registration Fees Related to HospitalsJune 29th, 2021

      A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals.  On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services …

    • New York Opioid Stewardship Act: Take 2 from the Second CircuitSeptember 16th, 2020

      On Monday, September 14, the United States Court of Appeals for the Second Circuit reversed the December 2018 opinion from the United States District Court for the Southern District of New York that invalidated the New York Opioid Stewardship Act (OSA).  In Association for Accessible …

    • State COVID-19 Response: Medical Marijuana and TelemedicineApril 7th, 2020

      State regulators across the healthcare professions continue to issue a number of guidances and waivers as part of the larger COVID-19 response.  We have previously blogged on a number of waivers issued by state pharmacy regulators in connection with COVID-19 response related to pharmacy staffing …

    • Update: State Controlled Substance Pharmacy Law Waivers and COVID-19 ResponseApril 2nd, 2020

      We previously blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19.  Waivers are being updated and added to state pharmacy websites daily to address the constantly changing public health and regulatory landscape.  This blog post addresses a …