Science & Technology

05
Dec
Quality Agreements Image

Quality Agreements a “Must Have” for Use of CMO

  The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing, processing, packing or holding). In addition, as […]

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01
Dec
Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance Image

Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down: Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from […]

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14
Nov
Upcoming eCTD Date for Technical Rejection Criteria for Study Data Image

Upcoming eCTD Date for Technical Rejection Criteria for Study Data

FDA has announced that study data standards are required for clinical and nonclinical studies that are started after December 17, 2017.  FDA notes that it may Refuse-to-File (RTF) NDAs and BLAs or Refuse-to-Receive ANDAs if the data does not conform to the standards outlined in the Guidance for Industry – Providing Regulatory Submissions In Electronic […]

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17
Oct

Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta

Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets.  The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in […]

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13
Oct

Getting a CRISPR View – Genetic Editing: Medical Frontier

Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”.  Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells.  While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted […]

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16
Sep

Data Governance – Establishing a Path Forward to Assure Data Integrity

Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety.  Companies are in a frenzy responding to regulatory citations and preparing for inspections.  The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated […]

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12
Sep

FDA Updates List of Guidance Documents It Plans to Issue in 2016

The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes: Comparative […]

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18
Aug

Follow-up on PIC/S Data Integrity Guidance

We recently posted an overall summary of the new draft PIC/S Data Integrity Guidance document (here). While this valuable Guidance document covers much of the same ground as previous Data Integrity Guidance documents from other regulatory agencies, it is particularly noteworthy that in several areas it provides detailed practical requirements heretofore never provided in a […]

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