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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	John Pinching PharmaTimes Next-gen biopharma company. La Jolla, California biopharmadrugsdevices	MHRA grants approval for bladder cancer drug erdafitinib - 18 days ago
3	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 - about 1 month ago Medtech Europe calls for urgent reform of MDR and IVDR - about 1 month ago FDA warns 2 Chinese labs for oversight failures, animal care violations - 2 months ago FDA sends 2 warning letters after inspecting Chinese syringe manufacturers - 4 months ago FDA creates communication ‘super office’ at CDRH - 4 months ago House committee tells FDA to suspend lab developed test rule - 4 months ago FDA finalizes guidance on studying opioid use disorder treatments - 5 months ago FDA to expand total product life cycle program - 5 months ago FDA creates transparency principles for AI in medical devices - 5 months ago UK regulator proposes recognizing overseas medical device approvals - 6 months ago EMA updates advice on drug-device combinations under MDR, IVDR - 6 months ago UK sets out position on regulating AI as a medical device - 7 months ago FDA seeks feedback on expansion of premarket cybersecurity guidance - 9 months ago FDA warns industry of ‘fraudulent’ third-party data in device applications - 9 months ago FDA authorizes record number of new devices in 2023 - 10 months ago UK shares roadmap for creation of new medtech regulatory framework - 11 months 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 - about 1 year ago FDA finalizes breakthrough device changes to target health inequities - about 1 year ago House committee tells FDA to suspend lab developed test rule - 4 months ago
4	Amy Baxter Pharma Voice Scientist, inventor, former pediatrician. Atlanta, Georgia pain relieftechnologyinnovation	3 FDA approval dates to watch in the year’s final push - 2 months ago FDA adcomm reform talks heat up - 3 months ago FDA’s platform designation aims to ease R&D pain points - 6 months ago As AI proliferates in pharma, regulators look to catch up in clinical trials - 7 months ago After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections - 9 months ago FDA inches closer to defining its regulatory role in AI - 10 months ago
5	Isabella Cueto STAT News Journalist on chronic disease. healthjournalism	FDA approves latest Covid vaccines, and Harris makes her case - 3 months ago
6	Ed Silverman STAT News Pharmalot columnist. Senior writer at STATnews. pharmaceutical industry	STAT+: U.K. trade group scolds Novo, Novartis, Pfizer, and Otsuka for violating industry codes - 5 months ago STAT+: European Parliament votes in favor of updated pharma legislation, prompting mixed reactions - 8 months ago STAT+: Pharmalittle: We’re reading about a liver-drug approval, pharma’s positive outlook, and more - 8 months ago STAT+: Pharmalittle: We are reading about Catalent concerns, a congressional hearing, and more - 10 months ago STAT+: Pharmalittle: We’re reading about FDA’s syphillis-drug plan, India’s manufacturer-inspection demands, and more - 11 months ago STAT+: Pharmalittle: We’re reading about Lilly selling drugs directly, UCB leaving BIO, and more news - 11 months ago STAT+: Pharmalittle: FDA approvals rebound, abortion pill orders rise, and more news - 11 months ago STAT+: FDA efforts to oversee foreign drug manufacturing remain inadequate to ensure safety, analysis finds - 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+: More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds - 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
7	Ashley Gallagher, Associate Editor Pharmacy Times One of Cabra girls on GoggleboxIRL. Dublin City, Ireland televisionentertainment	Study Finds Guidance Is Needed for Health Technology Assessments of Biosimilars - 6 months ago
8	Elise Reuter MedTech Dive Reporter @MedTechDive. Covers medical devices. medical technologydigital therapeutics	Cardinal receives FDA warning letter over unapproved syringes - 7 months ago CDRH’s Shuren backs expansion of TAP program to speed device approval - 9 months ago FDA drafts guidance outlining real-world evidence for medical device submissions - 11 months ago FDA withdraws from Global Harmonization Working Party - 12 months ago
9	Damian Garde STAT News Biotech reporter at STAT. Open to messages. biotechnologyjournalism	Merck’s next big thing is (probably) on the way - 8 months ago The FDA isn’t afraid to yank a disappointing drug - 9 months ago
10	Joyce Frieden MedPage Today Washington editor at MedPage Today. Board member at AHCJ. Greater Washington, DC area Healthcare journalism	House Committee Wrestles With Lab Test Regulation - 8 months ago FDA Approves Florida's Proposal to Import Prescription Drugs From Canada - 11 months ago

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