Tag: FDA

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

FDA Presented Guidance on Child-Resistant Packaging

The FDA published new guidance on Child-Resistant Packaging. The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include child-resistant packaging statements ...

FDA Called on Drug Compounders to be More Diligent with Suppliers

The US Food and Drug Administration (FDA) is calling on drug compounders to be more diligent with their suppliers to ensure that bulk active pharmaceutical ingredients they receive have been tested an...

FDA Publushed Draft Guide on Strengthening 510(k) Medical Device Program

medical-devices
The U.S. Food and Drug Administration announced that, as the first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuin...

PMRS Sued FDA for its Refusal to Approve New Opioid Capsule

Pharmaceutical Manufacturing Research Services (PMRS) has filed a petition asking the U.S. Court of Appeals for the District of Columbia Circuit to overturn the U.S. Food and Drug Administration's (FD...

FDA Released Draft Guidance on New Safer Technologies Program

The US Food and Drug Administration (FDA) released draft guidance to introduce a new, voluntary program for certain medical devices and device-led combination products that are expected to improve the...

FDA Classified 3P Biopharmaceuticals Facilities as Acceptable for Manufacture of Target Molecule

3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in process development and GMP manufacturing of biologics, has received FDA approval after completing th...

FDA Finalized Guidance on Citizen Petitions

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The US Food and Drug Administration (FDA) finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a...

Merck’s Investigational V920 Ebola Zaire Vaccine Accepted for Priority Review

ebola-vaccine
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority rev...

FDA Granted Breakthrough Therapy Designation to Roche’s Gazyva®

Roche announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Gazyva® (obinutuzumab) for adults with lupus nephritis. This designation was g...

FDA’s Committee Voted for AR101 Use for Treatment of Peanut Allergy in Children

A committee of the US Food and Drug Administration (FDA) has voted in favour of the use of Aimmune Therapeutics’ AR101 for the treatment of peanut allergy in children and teens. The Allergenic ...

FDA Awarded Three Grants to Support Development of COAs

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As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Eins...

Glenmark Multiple Myeloma Treatment Received ODD

Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its bispe...

FDA Granted Fast Track Designation for Development of Farxiga

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, ...

FDA Cleared Roche Cobas Pro® Integrated Solutions to Optimize Lab Operations

roche
Roche Diagnostics announced that the US Food and Drug Administration (FDA) has cleared its cobas pro® integrated solutions, a new generation of Serum Work Area (clinical chemistry and immunochemistry)...

FDA Approved South African’s Prevent Preterm Birth Med

The U.S. Food and Drug Administration (FDA) has approved Aspen Pharmacare’s hydroxyprogesterone caproate (HPC), which is used to prevent preterm birth in pregnant women, the South African drugmaker’s ...

FDA Alerted Patients that Zantac Contain Nitrosamine Impurity

fda office
The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosod...