Search Results for Regulatory Explainer

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Regulatory Explainer: The (Updated) 21st Century Cures Act By Alexander Gaffney, RAC - Published 30 April 2015

The US House Energy and Commerce (E&C) Committee has released an updated draft of a piece of legislation which proposes dramatically overhauling the way in which the US Food and Drug Administration (FDA) regulates many healthcare products.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Explainer, 21st Century Cures Act, 21st Century Cures Initiative, Cures Act, House, Legislation, Congress

Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program By Alexander Gaffney, RAC - Published 04 February 2014

In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Investigational IND, Early Access Program, Compassionate Use Program, Regulatory Explainer, Compassionate Use, IND, Expanded Access

Regulatory Explainer: What You Need to Know About the Regulation of Ebola Treatments By Alexander Gaffney, RAC - Published 07 August 2014

In this Regulatory Explainer, we're taking a look at the regulations that surround the development of a potential treatment or cure for Ebola, and why creating one is so conceptually difficult.

Categories: News, Africa, US, FDA, Ethics, Submission and registration

Tags: Ebola, Regulation of Ebola, Ebola Outbreak, Ebola FDA, Ebola Treatments, Regulatory Explainer

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? By Alexander Gaffney, RAC - Published 15 April 2014

Categories: US, FDA

Tags: Mobile App Guidance, Medical App, Regulatory Explainer, Mobile Medical App, Mobile App, Latest News, medical device

Regulatory Explainer: Understanding the Regulation of Generic Drug Labels By Alexander Gaffney, RAC - Published 08 April 2014

Categories: US, FDA, Labeling

Tags: Drug Labeling, Regulatory Explainer, Proposed Rule, CBE, Generic Drug Labeling Rule, Generic Drug, Latest News, pharmaceutical, drug

Regulatory Explainer: Understanding the Regulation of New Sunscreen Ingredients By Alexander Gaffney, RAC - Published 19 March 2014

Categories: US, FDA

Tags: How is Sunscreen Regulated?, FDA Regulation of Sunscreen, Regulation of Sunscreen, Regulatory Explainer, Sunscreen, Latest News

Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs By Alexander Gaffney, RAC - Published 17 March 2014

Categories: US, FDA

Tags: NDA Supplement, BA/BE, Regulatory Explainer, BA, Bioavailability, BE, IND, Latest News, pharmaceutical, bioequivalence, draft guidance, NDA

Regulatory Explainer: Making Sense of Humanitarian Use Devices By Alexander Gaffney, RAC - Published 17 March 2014

Categories: US, FDA, CDRH

Tags: Humanitarian Device Exemption, Regulatory Explainer, HDE, Latest News, humanitarian use device, HUD, guidance, medical device