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    The U.S. Food and Drug Administration ...

    FDA Approves First Generic Versions of Celecoxib

    The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid ...
  • Food, Drug &...
    The FDA recently released a draft ...

    Food, Drug & Device Law Alert – FDA Proposes Expedited Approval Program for PMA Medical Devices for Unmet Needs

    The FDA recently released a draft guidance document titled “Expedited Approval Program for Premarket Approval Medical Devices Intended for Unmet ...
  • AHIP CEO: In...
    Health care industry stakeholders should "begin ...

    AHIP CEO: Industry Must Address Rising Rx Drug Costs

    Health care industry stakeholders should "begin talking" about addressing rising prescription drug costs before the federal government is forced to ...
  • Catalyst Pha...
    CORAL GABLES, Fla., June 18, 2014.  ...

    Catalyst Pharmaceutical Partners Set to Join Russell Microcap(R) Index

    CORAL GABLES, Fla., June 18, 2014.  Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and ...

Pharmaceuticalshow all pharmaceutical articles

AHIP CEO: Industry Must Address Rising Rx Drug Costs
AHIP CEO: Industry Must Address Rising Rx Drug Costs

Health care industry stakeholders should “begin talking” about addressing rising prescription drug costs before the federal government is forced to step in, according to America’s Health Insurance Plans President and CEO Karen Ignagni, The Hill reports (Al-Faruque, The Hill, 5/21).

FDA Extends Comment Period on Draft Guidance that Could Require an IND for Cosmetics, Dietary Supplements and Food Research
FDA Extends Comment Period on Draft Guidance that Could Require an IND for Cosmetics, Dietary Supplements and Food Research

In September 2013, the FDA issued a draft Guidance titled, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND.”

Published Report: FDA on GDUFA
Published Report: FDA on GDUFA

The FDA has released its Performance Report for the first year of the Generic Drug User Fee Amendments (PDF downloadable at http://1.usa.gov/1dquler).

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Advertising & Marketingshow all advertising & marketing articles

FDA Wakes Up to Social Media’s Ability to Monitor Drug Adverse Events
FDA Wakes Up to Social Media’s Ability to Monitor Drug Adverse Events

Alec Gaffney reports that a recent FDA Notice of Solicitation (#1127679) calls for a “contractor capable of providing it with social media monitoring services capable of analyzing consumer sentiment and social media ‘buzz’” (read “Once Again, FDA Seeks to Leverage Social Media to Uncover Adverse Events and Public Sentiment“).”

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Eventsshow all events articles

Pharma Expo to Partner with PACK EXPO International in November
Pharma Expo to Partner with PACK EXPO International in November

Pharma EXPO will co-locate with PACK EXPO International, November 2 – 5, 2014, at McCormick Place in Chicago. Registration will open in Spring 2014. The show will focus on all phases of pharmaceutical manufacturing and its supply chain and conference sessions and exhibits to deliver:

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The New Government To Ponder: Is “Market Based Drug Pricing Policy” An ill Conceived One?
The New Government To Ponder: Is “Market Based Drug Pricing Policy” An ill Conceived One?

Contributed by Tapan J. Ray via PILMAN – A Tapan Ray Website on Healthcare According to a recent media report,

FDA Allows Marketing of First Prosthetic Arm
FDA Allows Marketing of First Prosthetic Arm

The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that

AHIP CEO: Industry Must Address Rising Rx Drug Costs
AHIP CEO: Industry Must Address Rising Rx Drug Costs

Health care industry stakeholders should “begin talking” about addressing rising prescription drug costs before the federal government is forced to

read more

Research & Developmentshow all research & development articles

Studies Find Existing and Experimental Drugs Active against MERS-Coronavirus
Studies Find Existing and Experimental Drugs Active against MERS-Coronavirus

WASHINGTON, DC – May 19, 2014 – A series of research articles published ahead of print in the journal Antimicrobial

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Regulatory Newsshow all regulatory news articles

FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body
FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body

The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic

AHIP CEO: Industry Must Address Rising Rx Drug Costs
AHIP CEO: Industry Must Address Rising Rx Drug Costs

Health care industry stakeholders should “begin talking” about addressing rising prescription drug costs before the federal government is forced to

FSMA Gets New Deadlines for Final Rules
FSMA Gets New Deadlines for Final Rules

The U.S. Food and Drug Administration has reached a settlement with the Center for Food Safety (CFS) and the Center

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FDA RegWatch is an affiliate of MedMarket Intelligence, LLC -- a health care solutions organization. Visit us at:t: http://www.MedMarketIntel.com

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