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2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more

FDA advises on RWE non-interventional study use as evidence of effectiveness or safety

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more

“Advancing Real-World Evidence Program” offers drug sponsors early FDA meeting opportunity

FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more

FDA outlines rescission of Breakthrough Therapy Designation - Guidance potentially signals closer agency scrutiny of designations...

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

FDA permits waivers of some REMS-required laboratory tests, imaging studies due to COVID-19

On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

DEA launches new ARCOS enhancement to help manufacturers and distributors "know your customer" and detect suspicious orders

The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that "will allow DEA-registered...more

Massachusetts anti-opioid law bans manufacturer copay assistance

On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately. ...more

U.S. House legislation highlights escalating government-wide focus on opioid abuse

On June 22 the U.S. House of Representatives passed sweeping legislation that represents "the biggest effort Congress has ever undertaken" to address the opioid epidemic, according to Rep. Greg Walden (R-OR). The House...more

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