FDA made it easier for compounders to make hydroxychloroquine and chloroquine by adding the anti-malaria drugs to the drug shortage list Tuesday (March 31), after receiving pressure from several compounding associations for the agency to list the drugs and make the formulations available for compounding by outsourcers.
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Rx Drugs
March 31, 2020 |
Daily News
FDA established a program to speed reviews of COVID-19 treatments and support research on COVID-19 drug candidates, the agency announced Tuesday (March 31).
March 31, 2020 |
Daily News
Attorneys general from 20 states and the District of Columbia called for FDA to ease risk mitigation requirements for abortion medication mifepristone, or at least allow certified prescribers to use telehealth to prescribe the drug during the COVID-19 pandemic.
March 30, 2020 |
Daily News
Kaiser Permanente’s updated chloroquine-rationing policy provides lupus patients with a 14-day refill of the drug, instead of a 90-day supply, and patients with other auto-immune diseases are being switched to alternative drugs to shore up supplies for COVID-19 patients.
March 30, 2020 |
Daily News
Health care providers and health care systems that administer hydroxychloroquine sulfate and chloroquine phosphate to patients as a potential COVID-19 treatment must track adverse events and report them to FDA within seven calendar days from onset of the event.
March 30, 2020 |
Daily News
HHS’ Biomedical Advanced Research and Development Authority, Janssen Research & Development and Moderna Therapeutics are working with FDA to streamline development and approval of the two companies’ potential COVID-19 vaccines, HHS announced Monday (March 30).
March 30, 2020 |
Daily News
Democratic leaders in the House and Senate health committees Friday (March 27) said they’ll fight to include in the next stimulus package a number of proposals aimed at expanding access to affordable health insurance and making COVID-19 vaccines and treatments free for all patients.
March 27, 2020 |
Daily News
President Trump on Friday (March 27) signed into law Congress’ phase three COVID-19 stimulus bill that includes a long-sought measure to reform FDA’s over-the-counter drug monograph regulatory framework.
March 27, 2020 |
Daily News
The Trump administration is working with COVID-19 vaccine developers to start producing their vaccines before they’re proven to work, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House coronavirus task force briefing Thursday night (March 26).
March 25, 2020 |
Daily News
Gilead on Wednesday (March 25) requested that FDA rescind orphan drug designation for the company’s investigational antiviral drug remdesivir after an outcry from public health consumer advocates who argued the designation would allow Gilead to benefit from market exclusivity and tax incentives that could cut out competition and raise prices for patients.
March 25, 2020 |
Daily News
The Senate’s draft stimulus compromise floated Wednesday (March 25) fails to include key FDA-related provisions that House Speaker Nancy Pelosi (D-CA) pushed for in her version of the stimulus package released earlier this week.
March 24, 2020 |
Daily News
FDA is allowing emergency use of investigational convalescent plasma, which involves using plasma collected from recovered COVID-19 patients as a potential therapy for the novel coronavirus disease.
March 24, 2020 |
Daily News
An updated draft of the Senate’s COVID-19 stimulus bill, floated Tuesday (March 24), includes over-the-counter drug monograph legislation that would establish an FDA user fee program for OTC drugs, give innovative OTC drugs 18 months of exclusivity and change the way FDA responds to OTC drug safety.
March 24, 2020 |
Daily News
A draft Senate COVID-19 stimulus compromise floated Tuesday (March 24) maintains multiple provisions that would expand requirements for drug makers to report product shortages, give FDA authority to require device makers report shortages and potential supply disruptions, and protect manufacturers of respiratory masks from lawsuits.
March 24, 2020 |
Daily News
In light of the COVID-19 pandemic, FDA says it will not take enforcement action against certain companies that do not submit adverse event reports to the agency within the standard required timeframe.
March 23, 2020 |
Daily News
This week, New York State will launch drug trials for a potential treatment for the novel coronavirus, New York State Gov. Andrew Cuomo (D) announced Sunday (March 22).
March 23, 2020 |
Daily News
FDA on Monday (March 23) announced new procedures that will allow the agency to issue COVID-19-related guidance documents as fast as possible.
March 23, 2020 |
Daily News
FDA announced Monday (March 23) that it will not take enforcement action against drug makers that don't conduct certain laboratory testing and imaging studies required by Risk Evaluation and Mitigation Strategies (REMS) amid the COVD-19 crisis.
March 22, 2020 |
Daily News
Senate Republicans attempted to remove language that would exempt drug shortage reports from Freedom of Information Act (FOIA) disclosures while adding in confidentiality language in their phase three COVID-19 package unveiled Sunday (March 22).
March 22, 2020 |
The Senate GOP’s third coronavirus stimulus bill includes several Medicare and Medicaid extenders, which jeopardizes the surprise billing and drug pricing policies that were excluded.
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