FDA Drug Info Rounds Video

Drug Info Rounds is a series of educational videos for health care professionals brought to you by the FDA’s Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI). DDI answers hundreds of questions daily about drug products and FDA actions. Our goal is to provide important and timely drug information to health care professionals on pertinent health topics so they can help patients make better medication decisions.

Videos

• MedWatch Tips and Tools
  FDA needs to know when a serious problem with a medical product is suspected or identified in clinical use. Learn how FDA’s MedWatch program makes it easy to get important safety information directly from you to us.
• Medication Guides: Distribution Requirements for Health Care Professionals (March 2020)
  Provides health care professionals with an overview of when Medication Guides may be required to distribute to a patient or caregiver.

• Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-up Submissions (September 2019)
  Provides instructions on completing Form FDA 3926 for follow-up submissions.

• Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions (September 2019)
  Provides instructions on completing Form FDA 3926, a one-page form, front and back for initial submissions.

• Expanded Access Part 2: How to Submit a Single Patient IND (September 2019)
  An overview on the submission process for emergency and non-emergency expanded access applications.

• Expanded Access Part 1: Introduction (May 2019)
  FDA Chief Project Manager Monica Hughes provides an introduction to Expanded Access for investigational medical products.

• FDA’s Role in Foreign Drug Manufacturing (November 2017)
  FDA Drug Info Rounds pharmacists discuss how FDA helps ensure that drug products distributed within the United States are safe to take.

• Definition of a Drug (April 2017)
  FDA Drug Info Rounds pharmacists discuss the key differences between the laws and regulations for drugs and cosmetics. 

• Combat Methamphetamine Epidemic Act (March 2017)
  FDA Drug Info Rounds pharmacists discuss the legal requirements for the over-the-counter purchase of drug products that contain pseudoephedrine.  

• Extortion Scam (September 2016)
  FDA Drug Info Rounds pharmacists discuss some simple steps to take if a potential victim receives an extortion call from FDA impersonators.

• REMS@FDA Tutorial (June 2016)
  FDA Drug Info Rounds pharmacists discuss FDA's new and improved REMS website called REMS@FDA.  

• Emergency Preparedness – Keeping Medications Safe (Feb 2016) 
  FDA Drug Info Rounds pharmacists discuss the importance of having a plan in place for keeping medications safe as part of emergency preparedness.  

• Breakthrough Therapy (December 2015)
  FDA Drug Info Rounds pharmacists discuss breakthrough therapy designation, an exciting new program to expedite drug development.

• Antibiotic Resistance (November 2015)
  FDA Drug Info Rounds pharmacists discuss how patients and pharmacists can play an important role in combating antibiotic resistance. 
• Medication Adherence (October 2015)
  FDA Drug Info Rounds Pharmacists discuss why medication adherence is so important.
• FAERS (April 2015)
  FDA Drug Info Rounds pharmacists provide some background information about the FAERS database.  
• NDC Directory (March 2015)
  FDA Drug Info Rounds pharmacists discuss changes to the online National Drug Code (or NDC) Directory. 
• REMS (February 2015)
  FDA Drug Info Rounds pharmacists discuss the many components of Risk Evaluation and Mitigation Strategies (REMS) and how they can help manage a drug product with known or potential serious risks.
• USP Salt Policy (December 2014)
  FDA Drug Info Rounds pharmacists discuss the application of the United States Pharmacopeia’s Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.
• Expanded Access (October 2014)
   FDA Drug Info Rounds pharmacists discuss expanded access to investigational drugs.
• Traveling with Prescription Medications (August 2014)
  FDA Drug Info Rounds pharmacists discuss key points pharmacists should counsel their patients on prior to travel.
• Managing Drug Shortages (July 2014)
  FDA Drug Info Rounds pharmacists discuss the management of drug shortages and how the FDA’s role has changed in recent years.
• Electronic Orange Book (March 2014)  
  FDA Drug Info Rounds pharmacists discuss how to search the Electronic Orange Book for generic equivalents, patents, and exclusivity.
• Drug Promotion (October 2013)
  FDA Drug Info Rounds pharmacists discuss the many elements surrounding the marketing and advertising of a prescription drug product.
• Drug Name Review (September 2013)
  FDA Drug Info Rounds pharmacists discuss FDA’s responsibility for reviewing and approving new product names.
• Communicating Benefit and Risk Information (August 2013)
  FDA Drug Info Rounds pharmacists talk about the benefit risk balance, and how health care professionals may approach this topic with their patients.

Please see the FDA Archive  for these topics:

• Drug Safety Communications (November 2012)
  FDA Drug Info Rounds pharmacists discuss how Drug Safety Communications let health care providers, patients, and consumers know about newly observed potential risks of FDA-approved drugs.
• Distribution of Medication Guides (October 2012)
  FDA Drug Info Rounds pharmacists discuss the requirements for providing Medication Guides.
• Medication Errors (September 2012)
  FDA Drug Info Rounds pharmacists discuss Medication Errors and how FDA educates the public about med­ication error prevention through public health advisories, medica­tion guides and outreach partner­ships with other organizations.  
• Patents and Exclusivity (August 2012)
  FDA Drug Info Rounds pharmacists discuss Patents and Exclusivity and how they work in a similar fashion but are distinctly different from one another. 
• Accelerated Approval Program (July 2012)
  FDA Drug Info Rounds pharmacists discuss the Accelerated Approval Program and how FDA helps make new, potentially lifesaving drugs available more quickly.

Additional Information

• Drug Info Rounds Podcast RSS
• FDA Drug Safety Podcasts

Resources For You

• Drug Information on Twitter
• Division of Drug Information (DDI)
• Drug Safety Communications