Michael Mezher
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Managing Editor @RAPSorg, covering FDA, EMA, pharma, biotech & medical devices.
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Articles by Michael Mezher
FDA to consider ‘innovative approaches’ to psychedelic drug development
FDA to consider ‘innovative approaches’ to psychedelic drug development Source: iStock Top US Food and Drug Administration (FDA) officials said the agency is open to novel, “innovative approaches” to the clinical development of psychedelic drugs in light of the worsening mental health crisis in the US. The agency’s evolving approach to psychedelic drugs was presented in a New England Journal of Medicine (NEJM) article published on Wednesday.
Recon: Makary’s fate as FDA commissioner up in the air; Roche to buy PathAI for $750M
Recon: Makary’s fate as FDA commissioner up in the air; Roche to buy PathAI for $750M Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Euro Convergence 2026: Facing transformation with community
Euro Convergence 2026: Facing transformation with community The healthcare product landscape in Europe is undergoing significant transformation—from multiple legislative overhauls to the rapid adoption of artificial intelligence (AI) and other boundary-pushing technologies. For regulatory professionals attending RAPS Euro Convergence 2026 in Lisbon, the meeting is an opportunity to lean into community to stay on top of the myriad changes coming their way.
Regulatory Focus - This Week at FDA: FDA names new Office of Compliance, CVM directors
Michael Mezher, Ferdous Al-Faruque, and Joanne S. Eglovitch Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that FDA has filled two leadership roles at the agency, and that it will host an upcoming patient-focused drug development (PFDD) meeting focused on long COVID.
This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more
This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more This Week at FDA | 02 December 2022 | By Michael Mezher • Ferdous Al-Faruque Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web.
This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more
This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more This Week at FDA | 18 November 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web.
Recon: FDA advisers back Ardelyx kidney disease drug; UnitedHealth to offer Humira alongside biosimilars next year
Recon: FDA advisers back Ardelyx kidney disease drug; UnitedHealth to offer Humira alongside biosimilars next year Recon | 17 November 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Recon: Walmart to settle opioid suits for $3.1B; Immunogen lands accelerated approval for ovarian cancer drug
Recon: Walmart to settle opioid suits for $3.1B; Immunogen lands accelerated approval for ovarian cancer drug Recon | 15 November 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Recon: Indivior to acquire Opiant for $145M; Roche Alzheimer’s drug fails in Phase 3 studies
Recon: Indivior to acquire Opiant for $145M; Roche Alzheimer’s drug fails in Phase 3 studies Recon | 14 November 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Recon: FDA Commissioner Califf tests positive for COVID; Veru surges on hopes for COVID drug EUA
Recon: FDA Commissioner Califf tests positive for COVID; Veru surges on hopes for COVID drug EUA Recon | 08 November 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
This Week at FDA: Califf on Twitter, ‘face-to-face’ meetings, and more
This Week at FDA: Califf on Twitter, ‘face-to-face’ meetings, and more This Week at FDA | 04 November 2022 | By Michael Mezher • Ferdous Al-Faruque Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web.
FDA sends warning letters to Lupin, Amazon and Walmart
FDA sends warning letters to Lupin, Amazon and Walmart Regulatory News | 01 November 2022 | By Michael Mezher The US Food and Drug Administration (FDA) last month warned Indian generic drugmaker Lupin Limited over three good manufacturing practice (GMP) violations at its facility in Maharashtra, India.
This Week at FDA: Former FDA commissioners push for reforms cut from user fee package
This Week at FDA: Former FDA commissioners push for reforms cut from user fee package Regulatory News | 14 October 2022 | By Michael Mezher • Ferdous Al-Faruque Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web.
Recon: FDA confirms widespread Adderall shortages; India finds violations at drugmaker linked to Gambia deaths
Recon: FDA confirms widespread Adderall shortages; India finds violations at drugmaker linked to Gambia deaths Recon | 13 October 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Recon: Pfizer, Moderna seek EUA for bivalent boosters for kids; Daiichi Sankyo wins Japanese approval for blood cancer drug Ezharmia
Recon: Pfizer, Moderna seek EUA for bivalent boosters for kids; Daiichi Sankyo wins Japanese approval for blood cancer drug Ezharmia Recon | 26 September 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
MDCG offers guidance on ‘appropriate surveillance’ under IVDR transition period
MDCG offers guidance on ‘appropriate surveillance’ under IVDR transition period Regulatory News | 20 September 2022 | By Michael Mezher The European Commission’s Medical Devices Coordination Group (MDCG) last week issued guidance offering in vitro diagnostic makers and notified bodies clarity on what constitutes “appropriate surveillance” of diagnostics during the In Vitro Diagnostic Medical Devices Regulation (IVDR) transition period.
Convergence: Marks admits 'knucklehead' messaging missteps with bivalent boosters, touts RWE for vac | RAPS
Convergence: Marks admits 'knucklehead' messaging missteps with bivalent boosters, touts RWE for vaccines Regulatory News | 13 September 2022 | By Michael Mezher Clockwise from top left: Phyllis Arthur, Amy Scott-Billman, Peter Marks, Marco Cavaleri PHOENIX, AZ – The US Food and Drug Administration’s (FDA) top vaccines regulator, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said that the agency could have better communicated the strength of the evidence it...
Recon: Akero drug meets goal in NASH study; Novartis to invest $300M in biologics operations
Recon: Akero drug meets goal in NASH study; Novartis to invest $300M in biologics operations Regulatory News | 13 September 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Recon: EMA recommends boosters targeting Omicron BA.4/5; FDA funding negotiations heat up as deadlin | RAPS
Recon: EMA recommends boosters targeting Omicron BA.4/5; FDA funding negotiations heat up as deadline looms Recon | 12 September 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
This Week at FDA: A ‘reasonable expectation’ for user fee reauthorization
This Week at FDA: A ‘reasonable expectation’ for user fee reauthorization This Week at FDA | 09 September 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. With Congress back in session and the end of the fiscal year rapidly approaching, attention once again turns to user fee reauthorization and appropriations.
Recon: FDA advisors back Amylyx ALS drug after second adcomm; Revance’s Botox rival wins FDA approva | RAPS
Recon: FDA advisors back Amylyx ALS drug after second adcomm; Revance’s Botox rival wins FDA approval Recon | 08 September 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
This Week at FDA: ACIP signs off on bivalent boosters
This Week at FDA: ACIP signs off on bivalent boosters This Week at FDA | 02 September 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to authorize bivalent COVID-19 vaccine boosters from Pfizer-BioNTech and Moderna.
Euro Roundup: EMA, Swissmedic recommend bivalent COVID vaccines
Euro Roundup: EMA, Swissmedic recommend bivalent COVID vaccines Roundups | 01 September 2022 | By Nick Paul Taylor, Michael Mezher Bivalent COVID-19 vaccines targeting the Omicron BA.1 subvariant developed by Pfizer-BioNTech and Moderna will soon be available in the EU, following a positive recommendation by a European Medicines Agency’s (EMA) committee.
This Week at FDA: Califf confirms no VRBPAC for bivalent boosters
This Week at FDA: Califf confirms no VRBPAC for bivalent boosters This Week at FDA | 26 August 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that both Pfizer and Moderna are seeking FDA authorization for their bivalent COVID-19 vaccines containing components of both the prototype virus and Omicron BA.4/5.
Recon: FDA approves Bluebird’s beta-thalassemia gene therapy; WHO recommends Valneva COVID vaccine
Recon: FDA approves Bluebird’s beta-thalassemia gene therapy; WHO recommends Valneva COVID vaccine Recon | 18 August 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
FDA updates 19-year-old replacement reagent policy for IVDs
FDA updates 19-year-old replacement reagent policy for IVDs Regulatory News | 18 August 2022 | By Michael Mezher The US Food and Drug Administration (FDA) on Tuesday finalized its guidance explaining its policies for replacement reagents and instrument families for in vitro diagnostics (IVDs), replacing an earlier policy issued in 2003. The guidance outlines FDA’s policy to allow IVD makers to avoid having to submit new 510(k)s for certain changes to their tests and supersedes the 2003 version.
Recon: Merck wagers $250M in circular RNA deal with Orna Therapeutics; US to send up to 442,000 Jynneos doses to states
Recon: Merck wagers $250M in circular RNA deal with Orna Therapeutics; US to send up to 442,000 Jynneos doses to states Recon | 16 August 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns
Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns Recon | 15 August 2022 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This Week at FDA: Amazon warning letter, ANDA amendments, and more
This Week at FDA: Amazon warning letter, ANDA amendments, and more This Week at FDA | 12 August 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we take a look at warning letters sent to online retail giant Amazon and two other companies for selling unapproved drugs for mole and skin tag removal.
FDA issues new recommendations to take on Covid-19 variants
The FDA on Monday unveiled recommendations for vaccine, drug and diagnostic test developers to address the impact of Covid-19 variants on the efficacy and performance of their products. The recommendations are made across four new and updated guidances targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests.
GAO calls on FDA to plan for backlog, review alternatives
In a nearly 350-page report to Congress on the federal government's Covid-19 response, the Government Accountability Office (GAO) calls on the FDA to review its inspections approach and come up with a plan to address its looming backlog.
CDER lays out 2021 guidance agenda
The FDA's Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021. The agenda, while oftentimes aspirational, provides insights as to what the agency's drug center's new guidance priorities are for the coming year. However, the list does not include draft or revised guidances the agency plans to finalize in 2021.
Biden institutes regulatory freeze on first day of presidency
In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird's stock value plummeted - as did those of multiple other biopharma companies developing similar therapies.
HHS, FDA dispute spills out onto Twitter
In the final months and weeks of the Trump administration, the Department of Health and Human Services (HHS) has advanced several policies to consolidate its authority over the US Food and Drug Administration's (FDA). Today, with just one day left in the Trump administration, the latest dispute between HHS and its subagency spilled into the public.
FDA offers new Q&A on biosimilars and interchangeable products
Posted 20 November 2020 | By Michael Mezher In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars. When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
Recon: UK asks MHRA to review Pfizer COVID vaccine; Novartis signs deal for Mesoblast cell therapy
Posted 20 November 2020 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
FDA, Industry set priorities for BsUFA III
Posted 19 November 2020 | By Michael Mezher At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US Food and Drug Administration (FDA) and industry shared their wish lists for the third iteration of the agency’s biosimilars review program.
FDA issues 34 new and revised product-specific guidances
Posted 18 November 2020 | By Michael Mezher In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances released by the agency to 1,974.
EMA revises remote pharmacovigilance inspections guide
Posted 18 November 2020 | By Michael Mezher The European Medicines Agency (EMA) has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic. The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis.
Recon: Judge approves $8.3B Purdue settlement; Congo declares end of Ebola outbreak
Posted 18 November 2020 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Hahn addresses EUAs, transition to approvals in conversation with RAPS members
Posted 17 November 2020 | By Michael Mezher Real-world data has proven useful in demonstrating the performance of COVID-19 diagnostics, but has not always lined up with the data submitted to support the emergency use authorizations (EUA) of those product. That was one message Stephen Hahn, MD, US Food and Drug Administration (FDA) commissioner brought to RAPS members during a conference call on Tuesday.
Recon: FDA delays decision on BMS’ liso-cel therapy; Amazon launches online pharmacy service
Posted 17 November 2020 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
FDA finalizes certificates of confidentiality guidance
Posted 16 November 2020 | By Michael Mezher The US Food and Drug Administration (FDA) finalized its guidance explaining how sponsors can request certificates of confidentiality (CoC) meant to protect the privacy of clinical trial participants. “By protecting researchers from being compelled to disclose identifiable, sensitive information about the research participants, CoCs help protect the identity of the research participants and achieve the objectives of the research,” FDA writes.
Recon: Moderna says COVID vaccine more than 94% effective; Drugmakers offer C$1B to fend off new Canadian pricing rules
Posted 16 November 2020 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
MDCG releases long-awaited IVD classification guidance
Posted 13 November 2020 | By Michael Mezher The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR).
Rasi signs off as EMA chief, Cooke to take the reins amid pandemic
Posted 13 November 2020 | By Michael Mezher Incoming Executive Director Emer Cooke Guido Rasi, the European Medicines Agency’s (EMA) long-serving executive director, ended his second five-year term on Friday, handing the reins to Emer Cooke, who is returning to the agency after a stint at the World Health Organization (WHO).
Recon: Swissmedic begins rolling review of Moderna COVID vaccine; COVAX raises $2B
Posted 13 November 2020 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Senate committee proposes $3.2B budget for FDA
Posted 12 November 2020 | By Michael Mezher The Senate Committee on Appropriations on Tuesday released draft legislation proposing $3.21 billion in discretionary funding for the US Food and Drug Administration for FY2021, closely matching the amount the agency would receive under the minibus passed in the House in July. In total, the draft bill would set FDA’s total FY2021 funding, including user fees, at $5.88 billion.
Recon: AstraZeneca cancer drug disappoints in COVID trial; Lawmakers seek changes to $8.3B Purdue settlement
Posted 12 November 2020 | By Michael Mezher Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Fauci stresses on need for equitable access of COVID-19 vaccines (Reuters) How Pfizer Plans to Distribute Its Vaccine (It’s Complicated) (NYTimes) Moderna close to revealing first data on whether its vaccine works (Politico) (FT) Pfizer says placebo patients will eventually get its Covid-19 vaccine.
PDUFA VII: FDA, Industry take up manufacturing, postmarket issues
Posted 11 November 2020 | By Michael Mezher In the latest meeting summaries released in the ongoing Prescription Drug User Fee Act (PDUFA) reauthorization negotiations, the US Food and Drug Administration (FDA) and industry set out their postmarket and manufacturing and inspections priorities for the next five-year program.
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