Report Store | Pharma intelligence
  • My Account
    • 0Shopping Cart
  • $0.00
  • Disease analysis
    • Anemias
    • Bacterial infections
    • Bleeding disorders
    • Brain Cancer
    • Breast and gynecological cancer
    • Cardiovascular and Metabolic
    • Central Nervous System
    • Cerebrovascular diseases
    • Dermatology
    • Diabetes and diabetic complications
    • Gastroenterology
    • Gastrointestinal cancer
    • Head and Neck Cancer
    • Hypertension
    • Immunology and Inflammation
    • Infectious Diseases
    • Ischemic heart disease
    • Leukemia
    • Lung Cancer
    • Lymphoma
    • Oncology overview
    • Market Spotlight
    • Mens Health
    • Neurology
    • Oncology
    • Ophthalmology
    • Other Hematological Cancers
    • Other metabolic diseases
    • Other Solid Cancers
    • Pain
    • Psychiatry
    • Respiratory
    • Rheumatology
    • Skin cancer
    • Thrombosis
    • Urological cancer
    • Vaccines
    • Viral infections
    • Women’s Health
  • Strategy analysis
    • Bleeding disorders
    • Breast and gynecological cancer
    • Cardiovascular and Metabolic
    • Central Nervous System
    • Commercial Strategy
    • Dealmaking and R&D
    • Head and Neck Cancer
    • Hot Topics
    • Infectious Diseases
    • KOL Insight
    • Leukemia
    • Lung Cancer
    • Manufacturing
    • Market Access
    • Neurology
    • Oncology
    • Outsourcing
    • Pricing & Reimbursement
    • R&D
    • Regulatory & Therapeutic Area
    • Trends
    • Urological cancer
  • Company analysis
    • Big Pharma
    • Emerging Pharma
    • Hot Topics
    • Japan Pharma
    • M&A Analysis
    • Mid Pharma
  • Drug analysis
    • A
    • B-C
    • D-F
    • G-L
    • M-O
    • P-R
    • S-T
    • U-Z
  • MedTech analysis
    • Allergy
    • Autoimmune / Immunology
    • Cardiovascular
    • Dermatology
    • Endocrine
    • ENT / Dental
    • Gastroenterology
    • Hearing
    • Hematology
    • Infectious Diseases
    • Metabolic
    • Neurology
    • Obstetrics / Gynecology
    • Oncology
    • Ophthalmology
    • Orthopedics
    • Osteoporosis
    • Psychiatry
    • Renal
    • Respiratory
    • Rheumatology
    • Urology
  • Opinion & analysis
    • Business Development
    • Business Management
    • Clinical Trials
    • Digital Health
    • Cybersecurity
    • Compliance & Risk
    • Digital patient management
    • Digital policy & regulation
    • Finance & Pricing
    • Healthcare Innovation
    • ICT and Health
    • Leadership
    • Legislation Regulation & Policy
    • Market Access
    • Market Intelligence
    • Medical
    • Pharmaceutical Device
    • Pharmaceutical Research
    • Strategy & Innovation
    • Tech companies & Data
    • Tech & Pharma
  • Blogs
  • Search
  • Menu
You are here: Home > Opinion & analysis

Opinion & analysis


loader
  • Sort by Custom
    • Default
    • Custom
    • Name
    • Price
    • Date
    • Popularity (sales)
    • Average rating
    • Relevance
    • Random
    • Product ID
  • Click to order products ascending
  • Display 15 Products per page
    • 15 Products per page
    • 30 Products per page
    • 45 Products per page

  • Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

    $131.00

    Names have not been made public, but two frontrunners have been chosen as contenders for notified bodies under the European Union’s new Medical Device Regulation. Find out who the frontrunners could be, and how timing is playing a critical role in this crucial announcement.

    October 24, 2018
    Find out more

  • Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?

    $200.00

    Two medical device manufacturers have been granted the first certificates under the EU’s new regulations that are coming into force next year. Medtech looks at whether this is a sign that the whole sector is going to be able to meet regulations.

    August 2, 2019
    Find out more

  • Two More EU Notified Bodies But Not On Nando Yet

    $131.00

    Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.

    August 2, 2019
    Find out more

  • UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

    $200.00

    Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.

    May 25, 2018
    Find out more

  • Unilever Seeks End To Litigation Over St. Ives Scrub, Plaintiffs’ ‘Fake Medical Condition’

    $131.00

    “Junk science” is being blamed for a lawsuit filed against Unilever for alleged “micro-tears” caused by their St. Ives Apricot Scrub. The suit, first filed in 2016, may be coming to the end of the road, as Unilever requests a summary judgement in the matter.

    October 24, 2018
    Find out more

  • US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

    $131.00

    The US FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.

    May 9, 2018
    Find out more

  • US FDA Looks To Standardize Premarketing Safety Assessments

    $131.00

    A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.

    August 2, 2019
    Find out more

  • US FDA May Largely Avoid House Democrats’ Investigation Agenda

    $131.00

    As Democrats gained a majority in the House after the 2018 US midterm elections, many wonder who will be on their radar when they turn their attention to holding hearings on drug pricing. The answer? It’s not likely to be the FDA.

    November 7, 2018
    Find out more

  • US FDA’s Gottlieb Shuts The Door On Exclusivity For ‘Transition’ Biologics

    $131.00

    Commissioner Scott Gottlieb announced that exclusivity for certain existing protein products will not be extended further, in remarks made at the FDA/CMS Summit. The announcement affects existing products, including insulin and human growth hormone, that, under the Public Health Service Act, are “deemed to be licensed” in 2020.

    December 11, 2018
    Find out more

  • US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

    $200.00

    After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.

    August 2, 2019
    Find out more

  • US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

    $131.00

    The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.

    August 2, 2019
    Find out more

  • US FDA’s Shutdown Offers One Possible Winner

    $131.00

    Find out the circumstances surrounding the unexpected positive results that the January 2019 US government shutdown (including the shutdown of US FDA) had on a breakthrough allergy immunotherapy in this thoughtful analysis from the industry experts at Pink Sheet.

    January 28, 2019
    Find out more

  • US FDA’s Temple on Real-world Evidence: “I Find the Whole Thing Very Frustrating”

    $131.00

    At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.

    September 2, 2019
    Find out more

  • US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

    $131.00

    Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.

    September 2, 2019
    Find out more

  • US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

    $200.00

    The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.

    May 1, 2018
    Find out more
Page 19 of 20
Page 19 of 20«‹17181920›
  • Home
  • Terms and Conditions
  • Refund policy
  • Privacy Policy
  • Cookie Policy
  • Contact Us
  • About Us
  • Discounts
  • Market Spotlight – Reports
  • twitter
  • linkedin
  • Sitemap
Datamonitor Healthcare is part of Pharma intelligence Datamonitor Healthcare is a trading division of Datamonitor Limited, a company registered in England and Wales with company number 2306113 whose registered office is 5 Howick Place, London, SW1P 1WG. VAT GB365462636. Datamonitor Limited is part of Informa PLC.

Sign up to the Pharma Intelligence Report Store Newsletter to get the latest blogs, news, reports and discounts!

Pharma Intelligence is part of the Business Intelligence Division of Informa PLC
  • Informa PLC
  • ABOUT US
  • INVESTOR RELATIONS
  • TALENT
This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726
informa
Call Back
Scroll to top