Drug Alerts and Statements

6/20/2024 FDA updates guidance on interchangeability 6/14/2024 FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen 4/15/2024 FDA establishes CDER Center for Clinical Trial Innovation (C3TI) 3/25/2024 CDER Establishes New Quantitative Medicine Center of Excellence 3/15/2024 FDA Announces New Quality Oversight Webpage 3/11/2024 FDA issues guidance regarding drug development for early Alzheimer’s disease 1/29/2024 FDA revises letter of authorization for the emergency use authorization for Paxlovid 1/23/2024 FDA’s ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience 12/21/2023 FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain 12/15/2023 FDA approves safety labeling changes for opioid pain medicines 10/17/2023 CDER soliciting comments regarding clinical trial innovation 9/21/2023 FDA issues guidance on using remote oversight tools to help approve drugs 9/18/2023 FDA issues draft guidance regarding confirmatory evidence of clinical trials 9/14/2023 FDA clarifies results of recent advisory committee meeting on oral phenylephrine 8/30/2023 DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems 5/23/2023 FDA issues final guidance on adjusting for covariates in randomized clinical trials 5/17/2023 FDA issues two draft guidances for industry to support the approval of pediatric drug products 5/11/2023 FDA requires updates to clarify labeling of prescription stimulants used to treat ADHD and other conditions 4/28/2023 FDA issues final Nicotine Replacement Therapy Drug Products guidance 4/13/2023 FDA announces new safety label changes for opioid pain medicines 4/4/2023 FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19 3/29/2023 FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance 1/20/2023 FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems 11/30/2022 FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region 11/4/2022 FDA Updates on Bebtelovimab 10/21/2022 FDA issues final guidance about multiple endpoints in clinical trials 10/12/2022 FDA Announces Shortage of Adderall 10/6/2022 FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute 10/3/2022 FDA Expands CDER NextGen Portal 9/8/2022 FDA draft guidance aims to improve consistency of labeling for nonprescription drugs 9/7/2022 CDER and CBER accept first submission to ISTAND Pilot Program 9/1/2022 FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute 8/9/2022 FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity 5/10/2022 CDER launches new Accelerating Rare disease Cures (ARC) program 4/19/2022 FDA works to protect consumers from potentially harmful OTC skin lightening products 2/25/2022 FDA updates Sotrovimab emergency use authorization 2/24/2022 FDA authorizes revisions to Evusheld dosing  2/24/2022 Approved first generic for Apokyn injection cartridges requires separately packaged pen 1/26/2022 FDA issues series of guidances under Drug Competition Action Plan 1/12/2022 FDA warns about risks of dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain  12/23/2021 FDA Urges Manufacturers to Develop Solutions for iPLEDGE REMS Website 10/20/2021 FDA issues refuse-to-file letter for application for Barth syndrome 9/16/2021 FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 7/30/2021 FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 7/14/2021 FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit 7/2/2021 FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level 5/19/21 FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments 3/26/2021 CDER perspective on recently published results of EPPPIC meta-analysis 3/18/2021 FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization 2/16/2021 FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia 12/10/2020 FDA will test ability to receive digital annotated ECG waveform files as agency prepares to transition to new ECG warehouse   12/4/2020 New studies show diabetes drug not proven to improve blood sugar control in pediatric patients 10/13/2020 FDA advises health care professionals and patients about insulin pen packaging and dispensing 10/5/2020 CDER proposes withdrawal of approval for Makena 8/26/2020 FDA works to mitigate shortages of rifampin and rifapentine after manufacturers find nitrosamine impurities 8/20/2020 FDA approves label changes to hydrochlorothiazide to describe small risk of non-melanoma skin cancer 3/19/2020 FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19 2/21/2020 FDA launches new resource to provide easily accessible, more accurate historical drug approval data 1/31/2010 FDA requests withdrawal of bacitracin for injection from market 1/30/2020 FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health 7/5/2019 FDA issues guidance on compounding oral oxitriptan (5-HTP) for patients with tetrahydrobiopterin (BH4) deficiency  5/21/2019 FDA issues draft guidance for industry on the design and evaluation of comparative analytical studies for biosimilarity 5/2/2019 Communications with stakeholders concerning access to compounded oral oxitriptan for patients with tetrahydrobiopterin deficiency 4/29/2019 FDA reminds imaging facilities to follow safety procedures for rubidium 82 generators used in Positron Emission Tomography (PET) myocardial perfusion imaging 3/21/2019 FDA warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma 9/26/2018 FDA announces new and expanded compounding research projects 9/20/2018 FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson’s disease psychosis 7/18/2018 FDA updates and press announcements on angiotensin II receptor blocker (ARB) recalls (Valsartan, Losartan, and Irbesartan) 6/28/2018 FDA approves labeling supplement for Celebrex (celecoxib) 6/21/2018 FDA withdraws draft guidance for industry: Statistical Approaches to Evaluate Analytical Similarity 5/22/2018 FDA video series about biosimilar and interchangeable products 5/18/2018 FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1 5/16/2018 FDA reports quality problems for data provided by the firm IQVIA that were used to inform estimates for some controlled substances 3/14/2018 FDA working with manufacturers to withdraw Zinbryta from the market in the United States 12/14/2017 FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 2017 11/14/2017 FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria 9/8/2017 FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen 8/31/2017 FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating KEYTRUDA® (pembrolizumab) in patients with multiple myeloma 8/4/2017 FDA warns consumers not to use Balguti Kesaria Ayurvedic Medicine due to high levels of lead 6/20/2017 FDA issues warning about body-building products labeled to contain steroid and steroid-like substances 5/22/2017 FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug product 4/13/2017 FDA announces Standard Homeopathic Company’s nationwide voluntary recall of Hyland’s teething tablets 1/17/2017 FDA approves a generic of Xyrem with a REMS Program 1/12/2017 FDA issues final guidance on repackaging and revised draft guidance on mixing, diluting, and repackaging biological products 1/10/2017 FDA warns cancer patients not to use PNC-27 products for treatment 1/9/2017 Impact of exclusivity on approval of Arymo ER 12/28/2016 FDA issues guidance on prescription requirement under section 503A 12/28/2016 FDA issues draft guidances on compounding and repackaging radiopharmaceuticals 12/15/2016 FDA proposes six bulk drug substances for inclusion on the 503A bulks list 10/25/2016 FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS) 10/17/2016 Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons 10/11/2016 FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device 10/6/2016 Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons 8/12/2016 FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks 8/3/2016 FDA issues draft guidance on insanitary conditions at compounding facilities 7/8/2016 FDA approves a dedicated syringe to be used with Humulin R U-500 insulin 7/7/2016 FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs 6/9/2016 FDA issues final guidances on interim policy for certain bulk drug substances used in compounding 5/26/2016 Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine 3/15/2016 FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals 1/22/2016 FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study

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