Drugs | FDA

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class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Drugs</h1> <h2 class="topic-subtitle text-center">The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States</h2> </div> </section> </header> <div class="field field--name-field-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">Topic Paragraphs</div> <div class="field--items"> <div class="field--item"> <section class="lcds-cta bg-lightest-gray txt-dark"> <div class="lcds-cta__media"> <div class="embed-responsive embed-responsive-16by9"> <div class="field field--name-field-video field--type-text field--label-above"> <div class="field--label">Call-To-Action Video</div> <div class="field--item"><iframe width="560" height="315" src="https://www.youtube.com/embed/zfnhrEWuRME?si=7ygZAGTWnEsslako" title="YouTube video player" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe></div> </div> </div> </div> <div class="lcds-cta__body"> <h2 class="lcds-cta__title"> <div class="field field--name-field-title field--type-string field--label-above"> <div class="field--label">Call-To-Action Title</div> <div class="field--item">Regulating and Approving Drugs Video Series</div> </div> </h2> <p class="lcds-cta__text">FDA uses science and data to ensure that approved drugs are of a high quality, safe, and effective. Learn more about the FDA鈥檚 role in reviewing, approving, and monitoring drugs in the latest videos that are now available in Spanish.</p> <a href="/drugs/information-consumers-and-patients-drugs/overview-our-role-regulating-and-approving-drugs-video-series" title="Learn more" class="btn btn-default"> Learn more </a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--audience lcds-card-deck bg-white txt-dark"> <div class="lcds-card-deck__body lcds-card-deck__body--audience"> <a href="/about-fda/cder-contact-information/ways-consumers-contact-fda-about-human-drugs" title="Consumer Contact Information" class="lcds-card--audience">Consumer Contact Information</a> <a href="/drugs/drug-safety-and-availability/drug-alerts-and-statements" title="Drug Alerts and Statements" class="lcds-card--audience">Drug Alerts and Statements</a> <a href="/drugs/news-events-human-drugs/whats-new-related-drugs" title="What's New Related to Drugs" class="lcds-card--audience">What's New Related to Drugs</a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck bg-blue txt-light"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Search our databases:</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm" title="Drugs@FDA"> Drugs@FDA</a></h3> <p class="lcds-card__text">Find information about most FDA-approved prescription, generic, and over-the-counter drug products.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://dps.fda.gov/drugshortages" title="Drug Shortages">Drug Shortages</a></h3> <p class="lcds-card__text">Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://dps.fda.gov/ndc" title="National Drug Code Directory Search">National Drug Code Directory Search</a></h3> <p class="lcds-card__text">Find information about finished drug products, unfinished drugs, and compounded drug products.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm" title="Orange Book">Orange Book</a></h3> <p class="lcds-card__text">The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.</p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">News</h2> </header> <div class="lcds-card-deck__body"> <a href="/drugs/our-perspective/our-perspective-omufa-past-current-and-future" title="Editorial highlights evolution of over-the-counter drugs and monograph reform"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=-uuXJyny 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=-uuXJyny 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=6Bhr9jmo 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=6Bhr9jmo 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=6Bhr9jmo 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=6Bhr9jmo 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/theresa-michele-fda-from-our-perspective-editorial.png?itok=6Bhr9jmo" width="420" height="220" alt="Theresa Michele, M.D." class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Editorial highlights evolution of over-the-counter drugs and monograph reform</h3> <p class="lcds-card__text">OMUFA program benefits patients, industry and U.S. healthcare system</p> </div> </article> </a> <a href="/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after" title="Proposed order seeks to remove active ingredient in nasal decongestant"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/woman-looking-at-medicine-in-aisle.png?itok=rskj44Bk 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/woman-looking-at-medicine-in-aisle.png?itok=rskj44Bk 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/woman-looking-at-medicine-in-aisle.png?itok=ZxfZTELs 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/woman-looking-at-medicine-in-aisle.png?itok=ZxfZTELs 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/woman-looking-at-medicine-in-aisle.png?itok=ZxfZTELs 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/woman-looking-at-medicine-in-aisle.png?itok=ZxfZTELs 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/woman-looking-at-medicine-in-aisle.png?itok=ZxfZTELs" width="420" height="220" alt="Shot of a young woman browsing the shelves of a pharmacy" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Proposed order seeks to remove active ingredient in nasal decongestant</h3> <p class="lcds-card__text">New data shows oral phenylephrine is safe, but not effective</p> </div> </article> </a> <a href="/news-events/fda-voices/fda-takes-exciting-steps-toward-establishing-rare-disease-innovation-hub" title="FDA takes steps toward establishing the Rare Disease Innovation Hub"> <article class="lcds-card lcds-card--promoted bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=K1jyk6vj 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=K1jyk6vj 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=AiKA_CGk 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=AiKA_CGk 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=AiKA_CGk 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=AiKA_CGk 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/homepage-rare-disease-innovation-hub-2024.jpg?itok=AiKA_CGk" width="420" height="220" alt="DNA structure on blue background with Rare Disease Innovation Hub text" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">FDA takes steps toward establishing the Rare Disease Innovation Hub</h3> <p class="lcds-card__text">Hub allows CDER and CBER to collaborate on cross-cutting rare disease issues</p> </div> </article> </a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Navigate the Drugs Section</h2> </header> <div class="lcds-card-deck__body"> 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