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Topic Big DataCuba Foreign Corrupt Practices Act (FCPA)Health Care Reform Telemedicine In the News Press Releases Media Contact Jill Chanen Public Relations Manager jchanen foley.com 312.832.4745 123next 15 February 2019 Beaver Discusses Advocate's Call for Requiring Food Companies to Identify Retailers in Recalls –Inside Health Policy Partner Nathan Beaver was quoted in an Inside Health Policy article, "Advocate: FDA Should Make Food Companies List Retailers in Recalls," about a food safety advocate's demand that food companies be required to disclose the names of retailers involved in recalls. 11 January 2019 Beaver Comments on Food Safety Threat During Government Shutdown –Law360 Partner Nathan Beaver was quoted in a Law360 article, “Government Shutdown Stretches FDA Food Safety Thin,” about the threat to food safety posed by the partial shutdown of the federal government. 08 January 2019 Faget Comments on Updates to FDA’s Pre-Cert Program –MobiHealthNews Special Counsel Kyle Faget was quoted in a MobiHealthNews article, “FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program,” about the FDA’s unveiling of new updates to its Digital Health Precertification (Pre-Cert) program. 19 December 2018 Geilfuss, Faget Comment on Implications of Possible ACA Ruling –Modern Healthcare Partner Fred Geilfuss and Special Counsel Kyle Faget were quoted in a Modern Healthcare article, “ACA repeal wouldn’t stop transition to value-based payment, efforts to lower drug spending,” about what would happen if the Affordable Care Act is ultimately held to be unconstitutional. 04 December 2018 Rosen Comments on Report That Found Flaws in FDA Drug Approval Process –Modern Healthcare Partner David Rosen was quoted in a Modern Healthcare article, "Federal investigation finds holes in orphan drug approval process," about an investigation by federal regulators that found fault with the U.S. Food and Drug Administration's process for approving so-called orphan drugs. 19 November 2018 Faget Comments on FDA Proposal to Streamline Premarket Review Submissions –MobiHealthNews Special Counsel Kyle Faget was quoted in a MobiHealthNews article, "Proposed framework lessens FDA's regulatory requirements for prescription drugs companion apps," about an FDA proposal that would classify most software released by pharmaceutical companies as "promotional labeling" not requiring premarket review. 18 October 2018 Beaver Comments on FDA Guidance Over Recalls –Inside Health Policy Partner Nathan Beaver was quoted in an Inside Health Policy article, "Food Industry Hopes FDA Is Judicious In Disclosing Retail Info In Recalls," about the FDA's recent guidance on disclosing food retailer information during certain recalls. 25 July 2018 Rosen Comments on FDA Plan to Facilitate Biosimilars –Regulatory Focus Partner David Rosen was quoted in an article in Regulatory Focus, “FDA Plans Hearing on Biosimilar Competition, Development,” about the U.S. Food and Drug Administration’s plan to hold a public hearing to gather input on how it can facilitate the development of biosimilars and help bring them to market in a timely fashion. 15 May 2018 Rosen Comments on Proposed Changes in FDA Drug-Device Rules –Bloomberg Law Partner David Rosen is quoted in a Bloomberg Law article, “Drug-Device Rules Could Give FDA Leg Up in Industry Fights,” about the FDA’s plan to revamp its rules on how to deal with overlapping drug, device and biologic products. 05 April 2018 Beaver Addresses Effect of New DOJ Policy on FDA Enforcement Actions –Food Quality & Safety Partner Nate Beaver was quoted in an article for Food Quality & Safety, “What DOJ’s Policy on FDA Guidance Really Means,” about the impact that a new Justice Department policy prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law will have on FDA enforcement actions. 123next Search News Filters applied: Search phrase entered: Sort results by: Most Recent Most Viewed Most Shared
15 February 2019 Beaver Discusses Advocate's Call for Requiring Food Companies to Identify Retailers in Recalls –Inside Health Policy Partner Nathan Beaver was quoted in an Inside Health Policy article, "Advocate: FDA Should Make Food Companies List Retailers in Recalls," about a food safety advocate's demand that food companies be required to disclose the names of retailers involved in recalls.
11 January 2019 Beaver Comments on Food Safety Threat During Government Shutdown –Law360 Partner Nathan Beaver was quoted in a Law360 article, “Government Shutdown Stretches FDA Food Safety Thin,” about the threat to food safety posed by the partial shutdown of the federal government.
08 January 2019 Faget Comments on Updates to FDA’s Pre-Cert Program –MobiHealthNews Special Counsel Kyle Faget was quoted in a MobiHealthNews article, “FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program,” about the FDA’s unveiling of new updates to its Digital Health Precertification (Pre-Cert) program.
19 December 2018 Geilfuss, Faget Comment on Implications of Possible ACA Ruling –Modern Healthcare Partner Fred Geilfuss and Special Counsel Kyle Faget were quoted in a Modern Healthcare article, “ACA repeal wouldn’t stop transition to value-based payment, efforts to lower drug spending,” about what would happen if the Affordable Care Act is ultimately held to be unconstitutional.
04 December 2018 Rosen Comments on Report That Found Flaws in FDA Drug Approval Process –Modern Healthcare Partner David Rosen was quoted in a Modern Healthcare article, "Federal investigation finds holes in orphan drug approval process," about an investigation by federal regulators that found fault with the U.S. Food and Drug Administration's process for approving so-called orphan drugs.
19 November 2018 Faget Comments on FDA Proposal to Streamline Premarket Review Submissions –MobiHealthNews Special Counsel Kyle Faget was quoted in a MobiHealthNews article, "Proposed framework lessens FDA's regulatory requirements for prescription drugs companion apps," about an FDA proposal that would classify most software released by pharmaceutical companies as "promotional labeling" not requiring premarket review.
18 October 2018 Beaver Comments on FDA Guidance Over Recalls –Inside Health Policy Partner Nathan Beaver was quoted in an Inside Health Policy article, "Food Industry Hopes FDA Is Judicious In Disclosing Retail Info In Recalls," about the FDA's recent guidance on disclosing food retailer information during certain recalls.
25 July 2018 Rosen Comments on FDA Plan to Facilitate Biosimilars –Regulatory Focus Partner David Rosen was quoted in an article in Regulatory Focus, “FDA Plans Hearing on Biosimilar Competition, Development,” about the U.S. Food and Drug Administration’s plan to hold a public hearing to gather input on how it can facilitate the development of biosimilars and help bring them to market in a timely fashion.
15 May 2018 Rosen Comments on Proposed Changes in FDA Drug-Device Rules –Bloomberg Law Partner David Rosen is quoted in a Bloomberg Law article, “Drug-Device Rules Could Give FDA Leg Up in Industry Fights,” about the FDA’s plan to revamp its rules on how to deal with overlapping drug, device and biologic products.
05 April 2018 Beaver Addresses Effect of New DOJ Policy on FDA Enforcement Actions –Food Quality & Safety Partner Nate Beaver was quoted in an article for Food Quality & Safety, “What DOJ’s Policy on FDA Guidance Really Means,” about the impact that a new Justice Department policy prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law will have on FDA enforcement actions.