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 Granted RDD Pharma’s Treatment with Fast Track Status

RDD Pharma, Inc., a specialty pharmaceutical company focused on development and commercialization of innovative therapeutics for anorectal and lower gastrointestinal disorders, announced that the U.S....

Dr. Reddy’s Launched Generic of Adcirca

Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s” announced the launch of Tadalafil Tablets USP, a therapeutic equivalent generic version of Adcirca (tad...

FDA Advisory Committee Voted For Janssen Depression Drug

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Manage...

Priority Review for Merck and Pfizer’s Treatment

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. has announced that the US Food and Drug Administration (FDA) had accepted for Priorit...

FDA’s Guide on Immunogenicity Testing of Therapeutic Protein Products

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For the evaluation of pharmacokinetics, pharmacodynamics, efficacy and safety of biological drugs and active substances, possible immunareactions of patients are of decisive importance. Especially in ...

FDA Final Guidance – Warning of Recalls

The U.S. Food and Drug Administration (FDA) recently released the final guidance entitled “Public Warning and Notification of Recalls.” The announcement of the guidance has been published in the Feder...

Two More Countries in EU-US Agreement of GMP Inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a leve...

FDA Warns 17 Companies for Selling Nonapproved Medicine

The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that...

BTD for FInch’s C. Difficile Drug

Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium dif...

Pilot Project for Drug Supply Chain Security Act of FDA

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A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products FDA regulates, including drugs available to consumers, are safe and of high quality. ...

Heritage Acquired 23 Approved ANDAs of 17 Product Families

Heritage Pharma Labs Inc. announced that they have acquired a portfolio of 23 abbreviated new drug applications (ANDAs), covering 17 product families, all of which have been previously approved by the...

USP Announced Generics Access Plan

USP announced its Generics Access Plan, helping to increase access to medicines by facilitating generics competition through new and revised quality standards and related activities, including collabo...

BTD for AstraZeneca’s LRTI Drug

AstraZeneca’s MEDI8897 has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract infection (LRTI) caused by respir...

Rare Disease Drug Approved, Receiving ODD

The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy,...

Swedish Company Received ODD for AIH Treatment

Calliditas Therapeutics AB today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Autoimmune hepatitis (AIH). A...

Roche Plans to Expand Use of its Breast Cancer Drug

Roche has submitted a supplemental biologics license application in the US seeking to expand the use of Kadcyla (trastuzumab emtansine) to include the adjuvant treatment of people with HER2-positive e...