Janet Woodcock and Department of Health and Human Services

Selected healthcare news for the person - Janet Woodcock, and the healthcare topic - Department of Health and Human Services We have 21 shared news items for this connection to-date.

Please provide a valid email address.

Selected Headlines

Date Headline (link) Source Relevant Snippet
4/16/2021 FDA walks back ‚Äòerror and ambiguity‚Äô-filled HHS proposal to exempt 91 devices from premarket review | FierceBiotech FierceBiotech ... on January 15, in the final days of the Trump administration. It was attributed to both the FDA and the Department of Health and Human Services. The notice permanently waived the required 510(k) premarket ... one unclassified device‚Aifrom premarket review.It was signed by Janet Woodcock, acting commissioner of the FDA, and Xavier Becerra, secretary of the HHS, both of whom are Biden administration appointees.RELATED: Hype collides with ...
4/12/2021 Cavazzoni to succeed Woodcock as the FDA's top drug reviewer | BioPharma Dive ... Janet Woodcock, was tapped to assist the Trump administration's coronavirus drug program last year. Cavazzoni's appointment comes as the FDA's leadership could soon change. Woodcock is currently serving as acting FDA commissioner, and is believed to be among the top candidates for the job. But President Joe Biden has yet to make a nomination even as several other top roles within U.S. Department of Health and Human Services, which oversees ...
3/10/2021 Biden to order 100M more COVID-19 vaccine doses from Johnson & Johnson ... Drug Administration.A White House official told FOX Business that Biden will announce that he is directing the team at the Department of Health and Human Services to procure an additional 100 million doses of the ... lives in the United States," said Acting FDA Commissioner Dr. Janet Woodcock . "The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during ...
3/10/2021 Biden to order 100M more COVID-19 vaccine doses from Johnson & Johnson ... Administration.A White House official told FOX Business that Biden will announce that he is directing the team at the Department of Health and Human Services to procure an additional 100 million doses of the ... in the United States,‚Au said Acting FDA Commissioner Dr. Janet Woodcock. ‚AuThe FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during ...
2/27/2021 FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting ... Biological Products Advisory Committee Meeting PR NewswireSILVER SPRING, Md., Feb. 26, 2021The following is attributed to Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics ... 888-INFO-FDAThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other ...
1/15/2021 US officials urge Americans to ask their doctors about monoclonal antibodies for COVID. But is it too little, too late? Yahoo News ... supply, but patients and providers are not taking advantage of them to treat COVID-19.In a briefing Thursday, the Department of Health and Human Services and Operation Warp Speed urged Americans to ask their ... who are at high risk of developing severe symptoms.Dr. Janet Woodcock, therapeutics lead for Operation Warp Speed, said the federal government has shipped more than half a million doses to more than 3,700 locations ...
1/14/2021 US officials urge Americans to ask their doctors about monoclonal antibodies for COVID. But is it too little, too late? ... supply, but patients and providers are not taking advantage of them to treat COVID-19.In a briefing Thursday, the Department of Health and Human Services and Operation Warp Speed urged Americans to ask their ... who are at high risk of developing severe symptoms.Dr. Janet Woodcock, therapeutics lead for Operation Warp Speed, said the federal government has shipped more than half a million doses to more than 3,700 locations ...
11/10/2020 U.S. to Start Distributing Lilly COVID-19 Antibody This Week U.S. News & World Report ... Department of Health and Human Services (HHS) Secretary Alex Azar said on Tuesday."Early treatment may help people avoid disease progression and avoid hospitalization," Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, said on a conference call along with Azar.The FDA on Monday gave emergency use authorization to Lilly’s antibody for anyone over age 65 who is recently diagnosed with mild ...
7/14/2020 Coronavirus vaccine development at ‘warp speed pace,’ officials say Washington Examiner ... Department of Health and Human Services told journalists on Monday. “Vaccine progress is occurring at warp speed pace, faster than any vaccine has been developed in history,” he said. “Therapeutics are even faster, and we believe we will have options for saving American lives as soon as early fall.” But Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research, admitted that though investments and purchases for ...
5/5/2020 Vaccine expert says he was punished for raising concerns about Trump’s coronavirus response, nepotism STAT ... Department of Health and Human Services. Among the most explosive accusations: Bright’s complaint alleges he was pressured by HHS Secretary Alex Azar to allow the distribution of hydroxychloroquine, a malaria drug, unproven as a Covid-19 treatment that has nevertheless been championed by President Trump. According to the complaint, Bright worked “frantically,” alongside top Food and Drug Administration official Janet Woodcock, to resist a plan to distribute the drug widely ...
11/6/2019 Statement from Center for Drug Evaluation and Research Director Janet Woodcock. M.D., on the agency's efforts to protect patients through postmarket drug safety surveillance practices PR Newswire ... all drugs and biologic products as part of our uncompromising efforts to protect the American public and ensure the products they take are safe and effective. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...
11/1/2019 Statement from Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research on new testing results, including low levels of impurities in ranitidine drugs PR Newswire ... American public. For more information: FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...
10/29/2019 Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on FDA's new report regarding root causes and potential solutions to drug shortages PR Newswire ... Information: Drug Shortages Biologics Drug Shortages Animal Drug Shortage Information FDA Voices: To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...
10/29/2019 Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts PR Newswire ... as a PDF. Review and tracking of these reports in paper or PDF format is inefficient and labor intensive," said Janet Woodcock , M.D., director of the FDA's Center for Drug Evaluation and Research. "The submission ... BA/BE Studies The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other ...
10/24/2019 Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock, M.D., on the agency's efforts to protect patients from potentially harmful drugs sold as homeopathic products PR Newswire ... and consumers to report adverse events or quality problems experienced with the use of any homeopathic drug products to the FDA's MedWatch Adverse Event Reporting program . The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...
9/25/2019 FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity PR Newswire ... keep the American public informed of any additional recalls as well as the potential risks from taking ranitidine products," said Janet Woodcock , M.D., director of the FDA's Center for Drug Evaluation and Research. The agency ... agency's MedWatch program . The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other ...
9/13/2019 Statement from FDA's Center for Drug Evaluation and Research Director Janet Woodcock, M.D., alerting patients and health care professionals of NDMA found in samples of ranitidine PR Newswire ... problem: Complete and submit the report online at www.fda.gov/medwatch/report.htm Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...
8/28/2019 Statement from Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency's ongoing efforts to resolve safety issue with ARB medications PR Newswire ... efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, effective, and quality drug products for the American public. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...
8/6/2019 FDA statement on court ruling related to compounded bulk drug substances and the agency's ongoing efforts to implement its compounding authorities PR Newswire ... Acting Commissioner of Food and Drugs - Food and Drug Administration Director of the FDA's Center for Drug Evaluation and Research Janet Woodcock , M.D. Late last week, a U.S. District Court judge in Washington, D.C. issued ... FDA Compounding Priorities The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other ...
7/2/2019 FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards PR Newswire ... legitimate supply chain – this is especially important within the context of the opioid crisis for those who handle opioids," said Janet Woodcock , M.D., director of the FDA's Center for Drug Evaluation and Research. "The supply ... Questions and Answers The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other ...
7/1/2019 Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research, on steps to make health care professional and patient labeling information for prescription medications consistent and clear PR Newswire ... drug and therapeutic classes. We encourage the public to comment on these draft guidances and will consider all comments as the agency works to finalize them. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is ...