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	Profile	Recent Articles on Subject
1	1387865 PharmaTimes PharmaTimes Media Ltd. Digital health news. Surrey, United Kingdom pharmahealthdigital healthmhealthNHSmarketingcommunicationsclinicaljobsMSL	NHS medicines access in jeopardy says ABPI - over 1 year ago
2	Nick Paul Taylor MedTech Dive Top 5 Mario Kart Player. Gaming	EMA creates advice portal for some high-risk medical devices - 20 days ago Tarver warns that US device supply chain vulnerabilities could harm patients - about 2 months ago European Parliament calls for proposals to reform MDR and IVDR by end of Q1 - 4 months ago Medtech Europe calls for urgent reform of MDR and IVDR - 5 months ago FDA sends 2 warning letters after inspecting Chinese syringe manufacturers - 7 months ago FDA creates communication ‘super office’ at CDRH - 8 months ago House committee tells FDA to suspend lab developed test rule - 8 months ago FDA finalizes guidance on studying opioid use disorder treatments - 8 months ago FDA to expand total product life cycle program - 8 months ago FDA creates transparency principles for AI in medical devices - 9 months ago UK regulator proposes recognizing overseas medical device approvals - 9 months ago EMA updates advice on drug-device combinations under MDR, IVDR - 10 months ago UK sets out position on regulating AI as a medical device - 10 months ago FDA seeks feedback on expansion of premarket cybersecurity guidance - 12 months ago FDA warns industry of ‘fraudulent’ third-party data in device applications - about 1 year ago FDA authorizes record number of new devices in 2023 - about 1 year ago UK shares roadmap for creation of new medtech regulatory framework - about 1 year ago FDA expands total product life cycle program to cover neurological devices - over 1 year ago FDA shares draft medical device harmonization plan to meet MDUFA V goal - over 1 year ago FDA finalizes breakthrough device changes to target health inequities - over 1 year ago House committee tells FDA to suspend lab developed test rule - 8 months ago
3	Ed Silverman STAT News Pharmalot columnist. Senior writer at STATnews. pharmaceutical industry	STAT+: Pharmalittle: We’re reading about an FDA hold on an Amgen obesity drug, imported Canadian drugs, and more - 27 days ago STAT+: U.K. trade group scolds Novo, Novartis, Pfizer, and Otsuka for violating industry codes - 8 months ago STAT+: European Parliament votes in favor of updated pharma legislation, prompting mixed reactions - 11 months ago STAT+: Pharmalittle: We’re reading about a liver-drug approval, pharma’s positive outlook, and more - 12 months ago STAT+: Pharmalittle: We are reading about Catalent concerns, a congressional hearing, and more - about 1 year ago STAT+: Pharmalittle: We’re reading about FDA’s syphillis-drug plan, India’s manufacturer-inspection demands, and more - about 1 year ago STAT+: Pharmalittle: We’re reading about Lilly selling drugs directly, UCB leaving BIO, and more news - about 1 year ago STAT+: Pharmalittle: FDA approvals rebound, abortion pill orders rise, and more news - about 1 year ago STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs - over 1 year ago STAT+: Pharmalittle: U.K. approves world’s first CRISPR-based medicine; FDA to review pricey cancer drug lacking confirmatory data - over 1 year ago STAT+: More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds - over 1 year ago STAT+: Pharmalittle: Pharma trade group slams European Commission proposal; U.S. lawmakers demand FDA explain its approach to shortages - over 1 year ago STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India - over 1 year ago STAT+: Pharmalittle: Pharma moves closer to a pricing deal with U.K.; FDA to review AstraZeneca request for self-administered flu vax - over 1 year ago
4	Michael Gibney Pharma Voice Teacher of English. Teacher of politics. Santiago, Chile educationpolitics	4 closely watched FDA approval dates in 2025 from J&J, Novo and more - about 2 months ago The FDA pushes concrete plans to further diversity in clinical trials - 8 months ago 4 big FDA approval dates to watch in 2024 - about 1 year ago Biopharma’s FTC headache deepens with guideline shifts years in the making - about 1 year ago
5	Frank Vinluan MedCity News Medical innovation tracker. MedCity, USA medicalinnovation	FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions - 2 months ago
6	John Pinching PharmaTimes Next-gen biopharma company. La Jolla, California biopharmadrugsdevices	UK regulator warns against buying weight-loss medicines without prescription - 2 months ago MHRA grants approval for bladder cancer drug erdafitinib - 4 months ago
7	Lizzy Lawrence STAT News Medical devices reporter at STATnews. Loves news tips. medical reportingnews	STAT+: 3 key issues to watch at the FDA as Trump takes office - 2 months ago
8	Meagan Parrish Pharma Voice Senior editor @industrydive. Pharma world follower. Wisconsin, USA pharmaceuticalsjournalismparenting	3 closely watched drugs that failed in the clinic - 3 months ago 3 recent FDA adcomm rejections — and why they matter - over 1 year ago
9	Amy Baxter Pharma Voice Scientist, inventor, former pediatrician. Atlanta, Georgia pain relieftechnologyinnovation	3 FDA approval dates to watch in the year’s final push - 6 months ago FDA adcomm reform talks heat up - 6 months ago FDA’s platform designation aims to ease R&D pain points - 9 months ago As AI proliferates in pharma, regulators look to catch up in clinical trials - 10 months ago After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections - about 1 year ago FDA inches closer to defining its regulatory role in AI - about 1 year ago
10	Elise Reuter MedTech Dive Reporter @MedTechDive. Covers medical devices. medical technologydigital therapeutics	Cardinal receives FDA warning letter over unapproved syringes - 10 months ago CDRH’s Shuren backs expansion of TAP program to speed device approval - about 1 year ago FDA drafts guidance outlining real-world evidence for medical device submissions - about 1 year ago FDA withdraws from Global Harmonization Working Party - over 1 year ago

Journalists covering medicines and healthcare products regulatory agency,drug approval process,drug approvals,fda approvals,united kingdom