Coronavirus Testing Delays in the United States: What Happened?
Testing for the novel coronavirus in the United States has not kept pace with the enormous demand despite national efforts to ramp up capacity.
More Outpatient Treatment Needed for Opioid Use Disorder
The treatment gap continues to be an obstacle in addressing opioid use disorder (OUD) in the U.S. In 2018, an estimated 2 million Americans had OUD but only about 26% received specialty addiction treatment.
America's Opioid Crisis: Outpatient Treatment is Effective and Accessible
More than 2 million Americans suffer from opioid use disorder, but only about 25% of people receive any sort of care. For many, inpatient treatment often means leaving a job and loved ones behind to seek recovery.
Dental Therapy Timeline, 2020
More than 56 million people in the United States live in areas with dentist shortages. Dental therapy is a proven solution that has helped increase access to care. Dental therapists are midlevel providers who deliver preventive and routine restorative treatment at schools, nursing homes, and veterans homes to people who would otherwise struggle to get access to care.
How COVID-19 Patients Can Access Investigational Drugs and Devices
The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.
Some Indicators of Public Health in Philadelphia Had Improved Before COVID-19
The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.
Pew Calls On DEA to Expedite Addiction Treatment Regulation
Pew’s substance use prevention and treatment initiative sent a letter to the Drug Enforcement Administration (DEA) on April 27 encouraging the agency to expedite a final rule that will help opioid treatment programs (OTPs)—federally regulated facilities where patients take medications for opioid use disorder under the supervision of medical staff and receive counseling and other care services—...
How COVID-19 Is Increasing Antibiotic Use
In the span of just a few short months, the ramifications and impact of COVID-19 have been vast. Virtually every aspect of public health has been affected by this pandemic, and the fight against antibiotic-resistant bacteria is no exception.
Opioid Use Disorder Treatment in Jails and Prisons
The most effective therapy for people with opioid use disorder (OUD) involves the use of Food and Drug Administration-approved medications—methadone, buprenorphine, and naltrexone. Despite evidence that this approach, known as medications for opioid use disorder (MOUD), reduces relapse and saves lives, the vast majority of jails and prisons do not offer this treatment. This brief examines what...
Care Coordination Strategies for Patients Can Improve Substance Use Disorder Outcomes
Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...
Policy Changes Could Bolster Prescription Drug Monitoring Programs
High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.
How States and Counties Can Help Individuals With Opioid Use Disorder Re-Enter Communities
At least 95 percent of individuals in state prisons will eventually return to communities. In fact, in a typical year more than half a million people do so, with many more coming from jails. A disproportionate share of these individuals have one or more chronic illnesses.
Policy Priorities to Address Opioid Use Disorder
Individuals with opioid use disorder (OUD) struggle to get effective care: Of 2 million Americans with the illness, only 26% receive treatment. Now, as the coronavirus pandemic presents an added strain on the U.S. health care system, it is creating greater hardships for those seeking OUD treatment.
Detailed Demographic Data Critical to Effective Coronavirus Response
Communities and policymakers working to meet the challenges of a global pandemic may need to take a range of targeted actions, such as building awareness, launching preventive measures, boosting health care infrastructure, or allocating emergency funding. These decisions, which can influence health outcomes significantly, highlight the importance of having the information needed to evaluate...
Six Ways New Federal Health IT Rules Improve Both Care and Public Health
The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.
HIAs and Other Resources to Advance Health-Informed Decisions
The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.
The Invaluable Role of Antibiotics—in a Pandemic and Beyond
The COVID-19 pandemic is providing a grim reminder of an unfortunate truism: Public health often does not receive the attention it deserves until a disaster hits.
Antibiotics Currently in Global Clinical Development
As of December 2019, approximately 41 new antibiotics with the potential to treat serious bacterial infections were in clinical development, and four were approved since the previous update in June 2019. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be...
What’s New Health Canada?
By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Updates from Health Canada New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the …
New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings
By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …
Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic
By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …
New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings
By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below. We note that approximately one-third of FDA’s guidances this past month are related to COVID-19. Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …
New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings
By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …
What’s New Health Canada? January and February 2020 Updates
By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Updates from Health Canada Type of Update and Link Date Posted Notice: Product Monograph Implementation Plans 13 January 2020 …
New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings
By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …
New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings
By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …
What’s New Health Canada? November 2019 Updates
By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Updates from Health Canada Type of Update and Link Date Posted Notice – Update to Clinical Trial Site Information Form 29 November …
New FDA guidance on alternate approaches in premarket notification for Class II medical devices
By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …
FDA grants emergency use authorization to Quidel for first antigen test for COVID-19
The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.
Half of Spaniards will see lockdown eased from Monday as death toll falls
Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.
Factbox: Latest on the worldwide spread of the coronavirus
More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.
Portugal's low-income households struggle to survive pandemic
One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday.
New York governor says 5-year old died from rare COVID-related complications
A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday.
Tijuana coronavirus death rate soars after hospital outbreaks
The number of deaths from the coronavirus in Mexico's best-known border city, Tijuana, has soared and the COVID-19 mortality rate is twice the national average, the health ministry says, after medical staff quickly fell ill as the outbreak rampaged through hospital wards.
Slovakia records no new coronavirus cases for first time since March 10
Slovakia on Friday recorded no new cases of coronavirus for the first time since March 10, government figures showed.
Malaysia reports 54 new coronavirus cases and one new death
Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589.
Indonesia reports 533 new COVID-19 cases, biggest in a day
Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.
Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi
Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.
Philippines' coronavirus deaths breach 700
The Philippines' health ministry reported on Saturday that coronavirus deaths have reached more than 700.
Russia records more than 10,000 new coronavirus cases in past day
Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676.
China approves Novartis' multiple sclerosis treatment Mayzent
Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.
Singapore reports 753 new coronavirus cases, taking total to 22,460
Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.
China to reform disease prevention system
China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.
Thailand reports four new coronavirus cases, one new death
Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January.
FDA commissioner in self-quarantine after exposure to person with COVID-19
U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.
China reports one new coronavirus case, 15 asymptomatic cases
China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday.
Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI
The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.
U.S. CDC reports 1,248,040 coronavirus cases, 75,477 deaths
The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477.
Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT
Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.
Gilead hit with Iranian cyberattack for role in COVID-19 response: report
Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.