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Rx Drugs

April 22, 2020 | Daily News

Outsourcing facilities worry FDA’s move to let pharmacists compound drugs for hospitalized COVID-19 patients without a prescription could hurt larger compounders and put patients at risk due to insufficient production standards.

April 21, 2020 | Daily News

A panel convened by the National Institutes of Health on Tuesday (April 21) recommended against using hydroxychloroquine, or any other drug, for treating or preventing COVID-19 outside of clinical trials.

April 21, 2020 | Daily News

Former FDA chief Scott Gottlieb and National Institutes of Health Director Francis Collins say regulators, researchers and the drug industry need to begin thinking about how to scale up manufacturing and test potential COVID-19 vaccines and therapies outside of large-scale randomized trials, especially as more promising products emerge later in the year.

April 21, 2020 | Daily News

FDA released a temporary guidance Monday (April 20) easing restrictions on pharmaceutical compounders in light of potential drug shortages caused by the spread of COVID-19.

April 20, 2020 | Daily News

The National Institutes of Health has teamed up with more than a dozen drug makers and regulators in the United States and Europe to do something U.S. government officials typically do their best to avoid: choosing which COVID-19 drug candidates get priority at the outset for government support that includes funding for late-stage testing, setting up those clinical trials, speeding through the regulatory processes and even sharing manufacturing facilities.

April 20, 2020 | Daily News

Novartis will move forward with a randomized phase III clinical trial of anti-malarial hydroxychloroquine for hospitalized COVID-19 patients, the company announced Monday (April 20).

April 17, 2020 | Daily News

Sen. Patty Murray (D-WA) on Friday (April 17) asked FDA Commissioner Stephen Hahn whether he was pressured by the White House on the agency’s COVID-19 response, specifically FDA’s emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat COVID-19, and asked Hahn to commit to base FDA’s decisions on science alone.

April 17, 2020 | Daily News

Sen. Michael Bennet (D-CO) is in the early stages of drafting a bill to establish an antimicrobial subscription model to encourage the development of innovative antimicrobial drugs.

April 17, 2020 | Daily News

FDA wants to develop a master protocol for COVID-19 vaccine clinical trials so that multiple vaccines can be developed more efficiently, agency chief Stephen Hahn said Thursday (April 16).

April 16, 2020 | Daily News

FDA may consider relaxing direct-to-consumer advertising for any future FDA-approved COVID-19 drugs, if the agency decides that the value and the benefits of a more relaxed approach outweigh the risks, agency chief Stephen Hahn said during an interview Thursday (April 16).

April 16, 2020 | Daily News

FDA issued a temporary policy on Thursday (April 16) allowing outsourcing facilities to compound drugs needed to treat hospitalized COVID-19 patients, even if the medication is not on the agency’s bulk shortage list.

April 16, 2020 | Daily News

Clinical research experts from Brigham and Women’s Hospital and Harvard Medical School warn against providing experimental COVID-19 therapies on a wide-scale basis, saying researchers and regulators should quickly conduct randomized, controlled clinical trials and uphold the standards of evidence-based medicine.

April 16, 2020 | Daily News

Sen. Ron Johnson wants the president to prohibit state officials from restricting the use of the Trump-touted hydroxychloroquine for treating COVID-19, and the Wisconsin Republican says Trump should direct FDA to broaden its emergency use authorization of the drug to make it easier for COVID-19 patients to get it.

April 16, 2020 | Daily News

Pharmacists say the Trump administration’s proposed rule to allow Canadian drug imports poses broad drug safety concerns for Americans due to lack of supply chain oversight and labeling issues.

April 16, 2020 | Daily News

The Trump administration’s plan to import drugs from Canada is facing resistance from drug makers who say that labeling requirements raise constitutional concerns and importing certain drugs with heightened safety concerns could hurt public health and cause confusion among patients.

April 16, 2020 | Daily News

Generic drug prices will likely increase due to supply disruptions caused by the coronavirus pandemic, according to Congress’ nonpartisan research arm, and industry analyst SVB Leerink says higher prices might hold long term.

April 15, 2020 | Daily News

Former FDA chiefs say the COVID-19 pandemic has brought about a need to gather evidence on potential therapies at breakneck speed, which they say can be done using data from the real world, but they also emphasize real-world evidence must complement, rather than replace, randomized trials and safety monitoring.

April 15, 2020 | Daily News

FDA has extended the deadline to apply for its real-world evidence funding project, which the agency launched April 7 amid discussions of RWE’s potential to bolster data for potential COVID-19 treatments.

April 14, 2020 | Daily News

As the COVID-19 outbreak causes numerous supply chain disruptions, one lawyer warns that stakeholders throughout the drug supply chain could file a barrage of international arbitration claims, as contractual agreements involving active pharmaceutical ingredient manufacturers, shipping companies and finished drug suppliers are broken due to delays caused by the global spread of the novel coronavirus.

April 13, 2020 | Daily News

FDA finalized two product-specific guidances for hydroxychloroquine sulfate and chloroquine phosphate to spur generic drug development, as states, federal agencies and other stakeholders undertake clinical trials and observational studies to explore whether either therapy could work as a treatment for COVID-19.

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