Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . Of course, the faster a safe and effective medicine can come to market, the better. See FDA Fact Sheet.

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FDA Law Blog

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

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FDA Law Blog

APRIL 21, 2024

Karst — If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. Patent and Trademark Office (“PTO”) for U.S.

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The Pharma Data

JANUARY 31, 2021

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE’s products advance the practice of dentistry and medicine for patients and healthcare professionals. About BIOLASE, Inc.

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The Pharma Data

DECEMBER 28, 2020

About Alkermes plc Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

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The Pharma Data

NOVEMBER 4, 2020

Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. President and Chief Executive Officer of Concert Pharmaceuticals. Recent Business Highlights and Upcoming Milestones. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020.

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Eye on FDA

MARCH 10, 2021

As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products.

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FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(B).

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”. Today, the U.S.

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The Pharma Data

MARCH 7, 2022

“Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. director of the FDA’s Center for Veterinary Medicine. “It

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Pfizer

DECEMBER 20, 2022

The extension of the NDA review period will not impact the Emergency Use Authorization (EUA) or the current availability of the medicine for eligible patients. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 13, 2022. COVID-19 Medicines Partnerships. COVID-19 Medicines. Disclosure Notice.

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XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

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The Pharma Data

DECEMBER 30, 2020

deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance: “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. .” SILVER SPRING, Md. , SOURCE U.S.

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Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 FDA Emergency Use Authorization Statement. IMPORTANT SAFETY INFORMATION.

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Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. Our Commitment to Access. IMPORTANT SAFETY INFORMATION.

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The Pharma Data

NOVEMBER 29, 2021

deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. Cytalux may cause fetal harm when administered to a pregnant woman. Source link: [link].

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FDA Law Blog

NOVEMBER 11, 2024

As those of us of a certain age remember, prior to 2005/2006, pseudoephedrine was the decongestant of choice for OTC multi-symptom cold medicine. As FDA explained, “The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine.”

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FDA Law Blog

OCTOBER 14, 2024

FDA also regulates HCT/Ps, defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient,” including bone, ligament, skin, cornea, stem cells derived from blood, and reproductive tissue. California Stem Cell Treatment Center, Inc.,

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The Pharma Data

DECEMBER 31, 2020

In December, the European Medicines Agency revealed that documents related to the COVID-19 vaccine developed by Pfizer and BioNTech maintained on the agency’s servers were illegally accessed. The idea is that the plasma, which contains antibodies against the virus, will be administered into patients who are critically ill.

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