Staff Writer

25
Jan

When a PMA Supplement is Needed | Regulatory Doctor

General Requirements for When a PMA Supplement is Needed  Examples of the types of modifications that require a PMA supplement (21 CFR 814.39(a)), if such changes affect the safety or effectiveness of the device, include, but are not limited to, the following: 1)      new indications for use of the device; 2)      labeling changes; 3)      the use of a different facility

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19
Jan

Management Consulting | Management Consultants | 360 View

Management Consulting | Management Consultants | 360 View We provide management consulting (360 views) to corporate management helping startups, young pharma, and device companies. How we do: We use our confidential and proprietary systematic assessment systems developed over the years.    We consider and use all factors for accurate and precise assessment under the circumstances. We identify root causes. We

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17
Jan

GCP for Medical Devices

Good Clinical Practice for Medical Devices FDA | GCP | Medical Devices | ASRs | LDTs | IDEs | HDE | Sponsors | IRBs | CIs | Informed Consent | 21 CFR Part 11 | HIPPA | DMC | ICH General 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review Boards and Sponsors

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17
Jan

Supreme Court of Alabama | Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling.

To Download A Copy of the Court Ruling, Please Fill Out the Form Below. Copyright © 2012  Regulatory Doctor.  All Rights Reserved. This web is hosted by Hostgator.