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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 - about 1 year ago
2	Sarah Owermohle STAT News Health reporter @STATNews. Covers Biden's agenda. Washington, District of Columbia health policyjournalism	STAT+: PBMs face scrutiny from all sides, and analyzing Marty Makary’s road to the FDA - 10 days ago STAT+: FDA’s latest reorganization puts a new emphasis on its investigations - about 1 year ago
3	Rebecca Pifer Healthcare Dive Reporter @healthcaredive. New York City, United States insurancedigital health	Sanofi sues HHS to defend 340B rebate policy - 11 days ago Guidance change threatens hospital 340B drug discounts - about 1 year ago
4	Ed Silverman STAT News Pharmalot columnist. Senior writer at STATnews. pharmaceutical industry	STAT+: South African regulator decides Vertex provides sufficient access to CF drugs, angering activists - 14 days ago STAT+: Pharmalittle: We’re reading about picking an FDA chief, a menopause film controversy, and more - about 1 month ago STAT+: Pharmalittle: We’re reading about FDA rejecting MDMA; a nasal spray for allergic reactions, and more - 5 months ago STAT+: U.K. trade group scolds Novo, Novartis, Pfizer, and Otsuka for violating industry codes - 6 months ago STAT+: European Parliament votes in favor of updated pharma legislation, prompting mixed reactions - 9 months ago STAT+: Pharmalittle: We’re reading about a liver-drug approval, pharma’s positive outlook, and more - 10 months ago STAT+: Pharmalittle: We are reading about Catalent concerns, a congressional hearing, and more - 11 months ago STAT+: European regulators tout their accomplishments against pharma’s anticompetitive practices - 11 months ago STAT+: Pharmalittle: We’re reading about Lilly selling drugs directly, UCB leaving BIO, and more news - 12 months ago STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs - about 1 year ago STAT+: Pharmalittle: U.K. approves world’s first CRISPR-based medicine; FDA to review pricey cancer drug lacking confirmatory data - about 1 year ago STAT+: Pharmalittle: FTC challenges ‘inaccurately or improperly’ listed patents; Elliott builds stake in BioMarin - about 1 year ago STAT+: Pharmalittle: Pharma trade group slams European Commission proposal; U.S. lawmakers demand FDA explain its approach to shortages - about 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 - about 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 - about 1 year ago
5	Ricky Zipp MedTech Dive Health Analyst, science master. Brooklyn, New York health analysisscience	Advamed CEO stresses need for safety, efficacy after Trump picks Makary to lead FDA - about 1 month ago AI oversight is top challenge facing global device regulators: FDA official - 10 months ago
6	Helen Branswell STAT News Frontiers of health & medicine reporting. healthmedicinejournalism	A Q&A with the FDA’s top vaccine regulator amid a fresh wave of disinformation - about 2 months ago
7	Elise Reuter Healthcare Dive Reporter @MedTechDive. Covers medical devices. medical technologydigital therapeutics	Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic. - about 2 months ago Tarver named new director of FDA’s device center - 2 months ago FDA official sets out approach to AI in medical devices - 6 months ago CDRH’s Shuren backs expansion of TAP program to speed device approval - 10 months ago FDA drafts guidance outlining real-world evidence for medical device submissions - about 1 year ago FDA withdraws from Global Harmonization Working Party - about 1 year ago
8	Nick Paul Taylor MedTech Dive Top 5 Mario Kart Player. Gaming	European Parliament calls for proposals to reform MDR and IVDR by end of Q1 - 2 months ago Medtech Europe calls for urgent reform of MDR and IVDR - 2 months ago Health officials outline industry role in AI oversight in JAMA article - 2 months ago FDA warns 2 Chinese labs for oversight failures, animal care violations - 4 months ago FDA sends 2 warning letters after inspecting Chinese syringe manufacturers - 5 months ago FDA creates communication ‘super office’ at CDRH - 5 months ago House committee tells FDA to suspend lab developed test rule - 6 months ago FDA finalizes guidance on studying opioid use disorder treatments - 6 months ago FDA to expand total product life cycle program - 6 months ago FDA creates transparency principles for AI in medical devices - 6 months ago UK regulator proposes recognizing overseas medical device approvals - 7 months ago EMA updates advice on drug-device combinations under MDR, IVDR - 7 months ago UK sets out position on regulating AI as a medical device - 8 months ago Mass General Brigham works with FDA to create brain-computer interface group - 10 months ago FDA seeks feedback on expansion of premarket cybersecurity guidance - 10 months ago FDA warns industry of ‘fraudulent’ third-party data in device applications - 10 months ago Medical device recall system ‘failing to meet the needs of public health,’ physicians find - 10 months ago FDA authorizes record number of new devices in 2023 - 11 months ago UK shares roadmap for creation of new medtech regulatory framework - 12 months ago FDA acts on industry call for clarity about scope of device shortage reporting rules - about 1 year ago FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices - about 1 year ago FDA expands total product life cycle program to cover neurological devices - about 1 year ago FDA shares draft medical device harmonization plan to meet MDUFA V goal - over 1 year ago Limited resources constrain federal oversight of medical device ads, GAO finds - over 1 year ago House committee tells FDA to suspend lab developed test rule - 6 months ago
9	N. Adam Brown MD MedPage Today Healthcare Strategist/Communicator. Washington, D.C. Healthcarestrategycommunication	Direct-to-Consumer Drugs: Big Pharma's Digital Health Play - 4 months ago
10	Amy Baxter Pharma Voice Scientist, inventor, former pediatrician. Atlanta, Georgia pain relieftechnologyinnovation	3 FDA approval dates to watch in the year’s final push - 4 months ago FDA adcomm reform talks heat up - 4 months ago After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections - 10 months ago FDA inches closer to defining its regulatory role in AI - 11 months ago

Journalists covering Medicine and Healthcare products Regulatory Agency