Tag: COVID-19

COVID-19

Regulatory/FDA

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Aug. 20, 2020 – The Food and Drug Administration’s (FDA’s) ability to approve new drugs while juggling new responsibilities during the COVID-19 pandemic appears to be exceeding expectations, with the agency approving 36 novel drugs to date in 2020, an increase from the 24 new molecular entities (NMEs) approved by this date in 2019 (with […]

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Washington Focus

Change in Hospital COVID-19 Case Reporting Raises Fear of Politicization of Data

Change in Hospital COVID-19 Case Reporting Raises Fear of Politicization of Data

July 20, 2020 – The Trump administration instructed hospital systems and providers last week that they should no longer report data on COVID-19 cases, hospitalizations, deaths, positive test results, etc. to the Centers for Disease Control and Prevention’s (CDC’s) National Healthcare Safety Network site, and instead should send this information to a newly launched data […]

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Legislative

Pharma Reputation on the Line During COVID-19 Crisis

Pharma Reputation on the Line During COVID-19 Crisis

June 29, 2020 – After being scrutinized for years regarding drug pricing issues, the biopharma industry is enjoying a boost in public opinion during the COVID-19 crisis. However, that boost may slowly be fading as lawmakers and the public continue to be skeptical of the industry, as evidenced by two bills introduced in the House […]

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Data Privacy

Pandemic Ups Need for Data Privacy Legislation, but 2020 Prospects Are Slim

Pandemic Ups Need for Data Privacy Legislation, but 2020 Prospects Are Slim

June 15, 2020 – The COVID-19 pandemic has brought increased use of telemedicine and group conferencing platforms, as well as prompted talk of using cellphones to do contact tracing, but this uptick in using technology in new and expanded ways also has increased the risks to personal data. Unfortunately, at a time when consumer data […]

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Regulatory/FDA

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

June 9, 2020 – Speaking at a June 1 presentation to the Alliance for a Stronger FDA, FDA Commissioner Dr. Stephen Hahn said that despite criticisms of its performance during the COVID-19 pandemic, FDA’s “decisions [will] always be rooted in science,” and that lessons learned during the pandemic “will lead to permanent improvements at the […]

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DTC Advertising

New Harris Poll Shows Pharma Industry Reputation Is Improving During COVID-19

New Harris Poll Shows Pharma Industry Reputation Is Improving During COVID-19

June 1, 2020 – Although the pharmaceutical industry’s reputation has taken a hit in recent years over drug-pricing concerns, the results of recent Harris Polls show that the industry’s role in helping to combat COVID-19 may be helping to rehabilitate its image. According to Harris Polls conducted between March 14 and May 17, 33 percent […]

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Data Privacy

Hackers Are Targeting COVID-19 Healthcare Data

Hackers Are Targeting COVID-19 Healthcare Data

May 18, 2020 – A joint alert issued recently by the U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the U.K. National Cyber Security Centre (NCSC) warns that they continue to see “indications that advanced persistent threat (APT) groups are exploiting the [COVID-19] pandemic” by targeting organizations involved in the COVID-19 response, including “healthcare bodies, […]

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Regulatory/FDA

As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]

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Regulatory/FDA

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

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Regulatory/FDA

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

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