The Pharma Data

MARCH 29, 2022

Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

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Vaccine Vaccination FDA Approval Immune Response 52

The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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Vaccine Vaccination Production Manufacturing 52

The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

Genomics 52

Genomics Genome Production Marketing 52

Cloudbyz

APRIL 12, 2022

As part of this partnership, ClinChoice will offer Cloudbyz’s digital clinical research solutions to their pharmaceutical, biotechnology, medical device, and consumer product clients. Product Marketing Manager 1-630-425-5475 marketing@cloudbyz.com. Follow us on: LinkedIn | Facebook | Twitter.

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Clinical Trials Clinical Trials Trials Clinical Research 52

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. Source link: [link].

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Vaccine Vaccination Clinical Trials Clinical Trials 40

The Pharma Data

APRIL 26, 2022

As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., The FDA urges the public to get vaccinated and receive a booster when eligible.

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FDA Approval Vaccine Vaccination Cosmetics 52

Pharmaceutical Technology

APRIL 18, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely.

Antibody 130

Antibody Cosmetics DNA Development 130

The Pharma Data

APRIL 18, 2022

Draft Guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act Food Allergies | FDA The Current Food Allergen Landscape | FDA. ###. effective Jan. The FDA, an agency within the U.S. Source link: [link].

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Allergies Cosmetics Production Drugs 52

Pfizer

AUGUST 15, 2022

I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world. Herbal Products: St.

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The Pharma Data

MARCH 29, 2022

an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Multiple samples of finished raw pet food products collected during the inspections tested positive for Salmonella.

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Manufacturing Contamination Cosmetics Regulation 52

The Pharma Data

DECEMBER 30, 2020

.” Additional Information: The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. The FDA is aware of at least 28 deaths and eight illnesses in dogs that ate the recalled product. This is an ongoing investigation.

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Production Cosmetics Compliance Containment 52

The Pharma Data

MAY 16, 2021

Product Name: Scientific Fat Loss. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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Production Cosmetics Hormones Doctors 52

The Pharma Data

APRIL 28, 2022

Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. Menthol product standard would have significant public health impact. Flavored cigar product standard would reduce youth risk.

Production 52

Production Cosmetics Regulation Manufacturing 52

Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Such systems provide control over the components used for the synthesis of target products making it easier to manipulate the contents according to specific needs.

Protein 52

Protein In-Vitro Reagent Production 52

The Pharma Data

MAY 17, 2021

The Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV) public-private initiative coordinated by the Foundation for the National Institutes of Health is one excellent example of master protocols being used to simultaneously study a number of promising drugs. Additional Information. Today, the U.S.

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Clinical Trials Clinical Trials Trials Cosmetics 52

The Pharma Data

DECEMBER 4, 2020

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. . . SOURCE U.S.

Cosmetics 52

Cosmetics Production Regulation Drugs 52

Pfizer

DECEMBER 13, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. Herbal Products: St. AUTHORIZED USE . IMPORTANT SAFETY INFORMATION

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Drugs Licensing Licensing Production 110

The Pharma Data

OCTOBER 22, 2020

of the Case Western Reserve University School of Medicine and University Hospitals Rainbow Babies & Children’s Hospital in Cleveland, discussed how pediatricians can advise parents on the effect of chemicals in consumer products on babies and children. In another session, Aparna Bole, M.D., Press Release. Lipkin, M.D.,

Vaccine 52

Vaccine Vaccination Production Cosmetics 52

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 complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

The Pharma Data

MAY 27, 2022

Some of this product is currently in stock for transport and additional product is being produced in the coming weeks and months. Department of Health and Human Services is evaluating options for getting the products to the U.S. The company has information about the products and where to find product once in the U.S.

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Production Manufacturing Cosmetics Allergies 52

The Pharma Data

MAY 27, 2022

“We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. These Neocate amino acid-based formula products — some of which are already manufactured for the U.S. Califf, M.D. “We as quickly as possible.

Production 52

Production Manufacturing Pharmacy Cosmetics 52

The Pharma Data

APRIL 15, 2022

At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month. ###. The FDA, an agency within the U.S. Source link: [link].

Radiology 52

Radiology Cosmetics Production Licensing 52

The Pharma Data

MAY 16, 2022

Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. of products manufactured here for export to foreign countries.

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Production Manufacturing Cosmetics Marketing 52

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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Drugs Regulation Manufacturing Medicine 55

The Pharma Data

FEBRUARY 24, 2022

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. Source link: [link].

FDA Approval 52

FDA Approval Cardiology Cosmetics Production 52

The Pharma Data

NOVEMBER 29, 2021

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. Source link: [link].

FDA Approval 52

FDA Approval Drugs Protein Cosmetics 52

The Pharma Data

APRIL 27, 2022

The FDA will work with manufacturers of these products to encourage the adoption of best practices to lower levels of lead in juice. Because lead is in the environment as a naturally occurring element and from consumer and industrial products and processes, it is not possible to remove it entirely from the food supply.

Cosmetics 52

Cosmetics Production Containment Contamination 52

Roots Analysis

FEBRUARY 20, 2022

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Role of nanoparticles has been well established across various markets, such as healthcare, paint, consumer products ( including sunscreens, cosmetics ), aerospace and glass industries.

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

The Pharma Data

DECEMBER 13, 2020

. “Today’s first ever approval of an animal biotechnology product for both food and as a potential source for biomedical use represents a tremendous milestone for scientific innovation,” said FDA Commissioner Stephen M. Hahn , M.D. Solomon , D.V.M., director of the FDA’s Center for Veterinary Medicine. In the U.S.,

FDA Approval 52

FDA Approval Genomics Genome Production 52

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. Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Pfizer’s total global revenue from the Prevnar family of vaccines was $6.34

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

APRIL 20, 2022

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. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Source link: [link].

Genetics 52

Genetics Cosmetics Radiology Production 52

The Pharma Data

JUNE 2, 2022

If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their healthcare professional. One reason for this recommendation is because some supplements might interact with medicines or other supplements. Source link: [link].

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Regulation Production Cosmetics Nurses 52

The Pharma Data

NOVEMBER 23, 2021

Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of mortal and veterinary medicines, vaccines and other natural products for mortal use, and medical bias. Source link: [link].

FDA Approval 52

FDA Approval Drugs DNA Cosmetics 52

The Pharma Data

NOVEMBER 21, 2021

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. Source link: [link].

FDA Approval 52

FDA Approval Drugs Regulation Genetics 52

The Pharma Data

SEPTEMBER 28, 2021

Department of Health and Human Services, protects the general public health by assuring the security , effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Source link: [link].

Contamination 52

Contamination Cosmetics Regulation Production 52

The Pharma Data

NOVEMBER 10, 2020

The firm recalled this product based on test results from a product sample collected and analyzed by MDARD, which determined that the strain of E. coli found in the product matches the strain causing a third distinct outbreak in the U.S. . On Nov. 6 , Tanimura & Antle, Inc. coli O157:H7.

Contamination 52

Contamination Packaging Packaging Production 52

XTalks

NOVEMBER 28, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). The USDA, on the other hand, oversees the safety of meat, poultry and egg products, among other responsibilities.

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Sales Regulation Containment Production 52