Top 10 Most Read Articles by Traffic in 2018
From Brexit to what’s coming at the US Food and Drug Administration (FDA), this year brought a variety of news that regulatory professionals needed to stay abreast of. Here’s a look at the top 10 articles by traffic in 2018.10. FDA Proposes New Option for Device Companies to Apply for 510(k) Clearance
This article focuses on a draft guidance on expanding FDA’s abbreviated 510(k) program as the agency looks to modernize its approach with moderate-risk devices.
9. Philips Medical Systems Draws Lengthy FDA 483 Over Issues with Thousands of Complaints
This article highlights a Form 483 sent to Philips Medical Systems after a 2017 inspection at a Cleveland-based manufacturing facility. FDA investigators found major issues with the handling of 133,845 complaints Philips had received from July 2016 through July 2017.
8. Six Asian Firms Blocked for Refusing FDA Inspections
This article focuses on the four Chinese, one Indian and one South Korea-based drug manufacturers added to FDA’s import alert list in August for failing to allow inspections.
7. The Drug Regulatory Landscape in the ASEAN Region
This article provides an overview of the regulatory requirements to be considered for Association of Southeast Asian Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling and drug variation information.
6. Brexit Guidance: MHRA Outlines What to Expect
This article focuses on the guidance from the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) explaining what pharmaceutical and medical device companies can expect during the period that the Brexit agreement is implemented.
5. FDA Unveils 6 new Draft Guidances on Gene Therapy
This article highlights the six new draft guidance documents focusing on developing hemophilia, rare disease and retinal disorder gene therapies, and include one on chemistry, manufacturing and control (CMC) information, one on long-term follow-up observational studies collecting data on adverse events and one on the testing of retroviral vector-based therapies.
4. Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance
This article discusses a final FDA guidance on when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
3. FDA Director Moves to AstraZeneca
This article focuses on several FDA employee departures and moves between the agency and industry.
2. FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
This recent article discusses FDA’s new real-world evidence (RWE) framework and how companies can win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements with RWE.
1. End of the eCTD? FDA Pushes for New KASA System to Improve Assessments
This article focuses on the positive aspects of adopting a Knowledge-aided Assessment & Structured Application (KASA) platform to replace the electronic common technical document (eCTD).