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What Will FDA Do In Battle Over Medication Abortion Access?

 
• By Brenda Sandburg

Attorneys discuss host of questions the agency faces in the wake of the Dobbs decision, including whether to take enforcement action against mifepristone REMS violations, whether to change restrictions on its use, and how to deal with challenges to its drug approval authority.

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FDA facing uncertainty as it grapples with post-Dobbs world • Source: Shutterstock

The US Food and Drug Administration is facing growing pressure from both those who want to expand access to medication abortion and those seeking to restrict or ban its use. As a result, the agency must address questions about the scope and enforcement of its Risk Evaluation and Mitigation Strategy (REMS) for mifepristone and how it responds to challenges of product approvals.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

 
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Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
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Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

More from Pink Sheet

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.