FDA Center for Drug Evaluation and Research: Drug Info Rounds FDA Center for Drug Evaluation and Research Drug Info Rounds Video Podcast https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm211957.htm en-us U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Info Rounds is a series of training videos for practicing clinical and community pharmacists. From the Center from Drug Evaluation and Research CDER, Center for Drug Evaluation and Research druginfo@fda.hhs.gov (CDER Division of Drug Information) no Wed, 18 Sep 2013 12:00 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) Definition of a Drug (April 2017) FDA Drug Info Rounds pharmacists discuss the key differences between the laws and regulations for drugs and cosmetics. Tue, 25 Apr 2017 16:40 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm545551.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm553114.htm FDA, Drug, Drug Information, Drug Info, Medicine, Meds, drug or cosmetic, regulation of drug, definition of a drug, drug definition, cosmetic, product intended use, cosmeceutical 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. Tue, 25 Apr 2017 16:40 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm545551.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm545551.htm CMEA, Combat Methamphetamine Epidemic Act, pseudoephedrine sale, pseudoephedrine purchase, NPLEx, OTC cold and allergy medications, Drug, Drug Information, Drug Info, Medicine, Meds, OTC meds, Sudafed, PSE 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. Tue, 21 Mar 2017 16:40 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm520948.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm520948.htm FDA, Food and Drug Administration, DIR, Drug Info Rounds, Drug, Drug Information, Drug Info, Medicine, Meds, extortion scam, extortion, scam, FDA impersonators, BeSafeRx REMS@FDA Tutorial (June 2016) FDA Drug Info Rounds pharmacists discuss the FDA’s new and improved REMS website called REMS@FDA. Tue, 21 Mar 2017 16:40 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm506677.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm506677.htm REMS@FDA, REMS, Risk, Risk Evaluation, Mitigation, Mitigation Strategy, Risk Evaluation and Mitigation, REMS materials, REMS documents, REMS data, FDA, Food and Drug Administration, DIR, Drug Info Rounds, Drug, Drug Information, Drug Info, Medicine, Meds Breakthrough Therapy (December 2015) FDA Drug Info Rounds pharmacists discuss breakthrough therapy designation, an exciting new program to expedite drug development. Tue, 21 Mar 2017 16:40 EDT http://wcms.fda.gov/FDAgov/Drugs/ResourcesForYou/HealthProfessionals/ucm474258.htm http://wcms.fda.gov/FDAgov/Drugs/ResourcesForYou/HealthProfessionals/ucm474258.htm FDA, Food and Drug Administration, drug, pharmacist, DIR, drug info, breakthrough therapy, breakthrough therapy designation, drug development, promising drugs, rolling review, priority review Antibiotic Resistance (November 2015) FDA Drug Info Rounds pharmacists discuss how patients and pharmacists can play an important role in combating antibiotic resistance. Mon, 30 Nov 2015 02:55 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm473189.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm473189.htm FDA, Food and Drug Administration, Antibiotics, Drug, Pharmacist, DIR, Drug Info, Medline Plus, Antibiotic resistance, combating antibiotic resistance, CDC Get Smart, respiratory illness, colds and flu, prevent antibiotic resistanc Medication Adherence (October 2015) FDA Drug Info Rounds Pharmacists discuss why medication adherence is so important. Mon, 30 Nov 2015 02:55 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm470165.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm470165.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, Medication Adherence, medication errors FAERS(April 2015) FDA Drug Info Rounds pharmacists provide some background information about the FAERS database. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm442182.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm442182.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors NDC Directory (March 2015) FDA Drug Info Rounds pharmacists discuss changes to the online National Drug Code (or NDC) Directory. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm437472.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm437472.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors 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. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm433705.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm433705.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors Disposal of Unused Medicines (January 2015) FDA Drug Info Rounds pharmacists discuss medication disposal options. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm429508.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm429508.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors 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. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm425653.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm425653.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors Expanded Access (October 2014) FDA Drug Info Rounds pharmacists discuss expanded access to investigational drugs. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm419877.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm419877.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors Traveling with Prescription Medications (August 2014) FDA Drug Info Rounds pharmacists discuss key points pharmacists should counsel their patients on prior to travel. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm410051.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm410051.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors 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. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm400243.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm400243.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors Electronic Orange Book (March 2014) FDA Drug Info Rounds pharmacists discuss how to search the Electronic Orange Book for generic equivalents, patents, and exclusivity. Thu, 18 Jun 2015 03:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm388798.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm388798.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors Drug Name Review FDA Drug Info Rounds pharmacists discuss FDA's responsibility for reviewing and approving new product names Wed, 18 Sep 2013 12:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm368620.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm368620.htm drug name, drug name review, proprietary drug names, DMEPA, OPDP, proposed proprietary names, medication errors Communicating Benefit and Risk Information FDA Drug Info Rounds pharmacists talk about the benefit risk balance, and how health care professionals may approach this topic with their patients. Fri, 23 Aug 2013 12:40 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm365624.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm365624.htm medication guides, medication benefit risk, risk information, communicating drug benefits and risk, safe and effective use, benefit risk balance Communicating Drug Safety Messages FDA Drug Info Rounds pharmacists discuss the vital role that pharmacists play in assisting the FDA with communicating drug safety messages. Wed, 20 Apr 2011 02:30 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm251790.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm251790.htm drug safety, Listserv, drug safety podcasts, drug information, FDA widget, FDA Drug Info Twitter, FDA social media, adverse events, MedWatch. Drug Shortages Video FDA Drug Info Rounds pharmacists discuss FDA's role in responding to and mitigating drug shortages. Wed, 01 Dec 2010 10:24 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm235347.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm235347.htm drug shortages, drug safey Evamist Video FDA Drug Info Rounds pharmacists discuss FDA's ongoing safety review of adverse event reports in children who may have been unintentionally exposed to the drug through skin contact with women using Evamist. Fri, 01 Oct 2010 08:24 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm227864.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm227864.htm Evamist, drug safey Proton Pump Inhibitors (PPIs) Video FDA Drug Info Rounds pharmacists discuss new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, strengths and limitations of the studies, and recommendations for pharmacists. Mon, 09 Aug 2010 12:55 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm221672.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm221672.htm Proton Pump Inhibitors, PPIs, fractures Long-Acting Beta-Agonists (LABAs) Video Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. Mon, 26 Jul 2010 10:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm219161.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm219161.htm Long-Acting Beta-Agnoists, LABAs, asthma, chronic pulmonary disease Single-Ingredient Oral Colchicine Video FDA Drug Info Rounds pharmacists discuss the differences between approved and unapproved colchicine products, concerns regarding unapproved single-ingredient oral colchicine, and how patients can offset the increased cost of Colcrys. Mon, 26 Jul 2010 10:00 EDT https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm211975.htm https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm211975.htm Drug Safety, Colchicine, Colcrys