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Tag: FDA

Most Recent Changes to the IID Database | FDA

August 1, 2020 Blogger

Most Recent Changes to the Inactive Ingredient Database — Read on www.fda.gov/drugs/drug-approvals-and-databases/most-recent-changes-iid-database

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Posted in: Excipients Filed under: FDA, IID

The History, Benefits of Pharmaceutical REMS Programs

February 2, 2020 Blogger

Some REMS programs may only require a medication guide to be distributed with each dispense that highlight safety information, such…

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Posted in: Health Technology Filed under: FDA

FDA approves first drug for treatment of peanut allergy for children

February 1, 2020 Blogger

FDA approves first drug for treatment of peanut allergy for children — Read on s2027422842.t.en25.com/e/es This is a huge achievement…

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Posted in: Health Technology Filed under: approvals, FDA, pdufa, technology

First Generic Drug Approvals | FDA

January 11, 2020 Blogger

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides…

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Posted in: Uncategorized Filed under: approvals, FDA, gdufa

FDA In Brief: New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry

December 13, 2019 Blogger

FDA In Brief: New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts…

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Posted in: Health Technology Filed under: FDA, gdufa, RLD

FDA grants accelerated approval to first targeted treatment for rare Duchenne Muscular Dystrophy (DMD) mutation – Drug Information Update

Blogger

FDA grants accelerated approval to first targeted treatment for rare Duchenne Muscular Dystrophy (DMD) mutation – Drug Information Update —…

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Posted in: Health Technology Filed under: approvals, FDA, pdufa

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

Blogger

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic — Read on s2027422842.t.en25.com/e/es

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Posted in: Uncategorized Filed under: approvals, FDA, gdufa

NIH to investigate minor cannabinoids and terpenes for potential pain-relieving properties | NCCIH

December 11, 2019 Blogger

This press release highlights new NCCIH research awards totaling approximately $3 million to investigate the potential pain-relieving properties and mechanisms…

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Posted in: Health Technology Filed under: FDA

Drug Trials Snapshots BRUKINSA | FDA

December 1, 2019 Blogger

Drug Trials Snapshots — Read on www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-brukinsa More inhibitors for oncology.

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Posted in: Health Technology Filed under: approvals, FDA, pdufa

FDA Report: Changes in Marketplace Needed to Mitigate Drug Shortages

November 3, 2019 Blogger

The FDA Drug Shortages Task Force addressed the root causes of drug shortages and proposed potential solutions. — Read on…

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Posted in: Health Technology Filed under: FDA

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  • Most Recent Changes to the IID Database | FDA
  • The History, Benefits of Pharmaceutical REMS Programs
  • FDA approves first drug for treatment of peanut allergy for children

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