The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. , .

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The Pharma Data

APRIL 20, 2022

All NIPS tests on the market today are offered as laboratory developed tests (LDTs). While LDTs are medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA has had a general policy of enforcement discretion for most LDTs since the Medical Device Amendments were enacted in 1976.

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

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The Pharma Data

APRIL 7, 2023

The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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The Pharma Data

NOVEMBER 21, 2021

A condition of this accelerated approval is a post-marketing study that will assess final adult height. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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The Pharma Data

MARCH 15, 2022

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

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The Pharma Data

MAY 27, 2022

market and are made at facilities in Europe — amounts to more than 5 million full-size, 8-ounce bottles. Last week, the FDA issued guidance that outlined a process by which the FDA would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S.

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The Pharma Data

MAY 16, 2022

We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. to do so efficiently and safely. of products manufactured here for export to foreign countries.

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The Pharma Data

MAY 27, 2022

The FDA issued guidance on May 24 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries.

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The Pharma Data

NOVEMBER 12, 2021

An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Analogous testing handed by Philips Respironics to the FDA on bias authorized for marketing in theU.S.

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Pharma in Brief

JANUARY 10, 2024

Changes in Canada’s pricing and market access regimes This year saw major developments in the drug price and reimbursement space, including at the Patented Medicine Prices Review Board ( PMPRB ), the pan-Canadian Pharmaceutical Alliance ( pCPA ), and the Canadian Agency for Drugs and Technologies in Health ( CADTH ). Rare disease strategy.

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The Pharma Data

DECEMBER 13, 2020

. As part of its review, the FDA evaluated the safety of the IGA for the animals and people eating meat from them, as well as the product developer’s intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs’ cells. . . SOURCE U.S.

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XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed. What is a Biosimilar?

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Pfizer

DECEMBER 13, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. Research Vaccines. COVID-19 Research Vaccines. 12.09.2022. 11.23.2022.

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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. Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations.

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Pfizer

NOVEMBER 23, 2022

Expanding Access to Patent-Protected Medicines in Lower-Income Countries : Launched An Accord for a Healthier World , a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S.

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Pharmacy Checkers

JUNE 26, 2020

As reported by Regulatory Focus: “The regulators went over challenges each are facing in the race to develop vaccines for COVID-19 and make them available. It’s noteworthy that the law permitting importation, Section 804 of the Food, Drug and Cosmetic Act, replaced the statute of the Medicines Equity and Drug Safety Act of 2000 (MEDS Act).

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Pfizer

DECEMBER 20, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. Research Vaccines. IMPORTANT SAFETY INFORMATION. Pfizer to Provide U.S.

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. The FDA granted the marketing authorization to Global Protection Corp. Today, the U.S. Related Information. The FDA, an agency within the U.S.

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