India sometimes describes itself as the “pharmacy to the world” because it is a significant global supplier of affordable therapeutics, including many life-saving medicines for chronic conditions. For the U. S., where more than nine out of 10 prescriptions dispensed are generic drugs, India is a critical partner, responsible for a substantial portion of these drugs. I recently visited India with a central purpose in mind—to strengthen our collective efforts to advance the development and availability of medical products that both our countries and the rest of the world needs.
Fifteen years ago, the U.S. Food and Drug Administration recognized India’s strategic importance to the U.S.—and to the agency in fulfilling our mission—and opened one of the FDA’s first foreign offices in India. Since that time, the Indian medical products sector has continued to grow as has our reliance on medical products made in India. These were drivers for my decision to travel to India where I met with Government of India officials, pharmaceutical company CEOs, academics, clinical researchers and innovators.
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By Paige Minemyer
October 27, 2023
This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
"Amazon Pharmacy is focused on making it faster and more convenient for patients to get prescription medications. The company's moves come as brick-and-mortar drugstores are limiting pharmacy hours and even closing locations." - Heather Landi
Hospital 340B drug pricing program policy reversal a 'gut punch' |
The federal government reversed a policy designed to streamline 340B certifications during the COVID-19 pandemic. |
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| Hygienic Labs, LLC | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records |
| Abbott Laboratories | Center for Biologics Evaluation and Research (CBER) | Dietary Supplement/Adulterated | ||||
| Golden Natural Products | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Embryll Life Sciences, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated | ||||
| Suther Feeds, Inc. | Division of Human and Animal Food Operations West II | CGMP/Medicated Feeds/Adulterated |
Congress eyes endgame for PBM legislation |
Pharmacy benefit managers such as CVS Caremark, Express Scripts and Optum Rx face new transparency rules and restrictions on how they make money under a legislative package coalescing on Capitol Hill. |
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| Abiomed Inc. | Division of Medical Device and Radiological Health Operations East | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | ||
| www.gorillahealing.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||
| Antonio E. Blanco, M.D./Vista Health Research, LLC | Center for Drug Evaluation and Research | CDER | Clinical Investigator | ||
| www.semaspace.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||
| www.alphamedstore.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||
| MKK Imports | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||
| Seoul Cosmetics Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
| Tijuana’s Produce Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||
| Ikal LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||
| Kari-Fresh LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
