Eye on FDA

FEBRUARY 8, 2024

This year the agency issued 190 releases, which is a substantial cutback from recent years in terms of sheer numbers. The last time the agency issued less than 200 releases to the public was back in 2017. In any case, no doubt about it, the agency volume of traditional releases has subsided greatly. What Did They Talk About?

Communication 75

Communication Vaccines 75

Eye on FDA

FEBRUARY 10, 2021

Last month we looked at a review of FDA press releases for last year and as one might have expected, there was an enormous spike in communications as a result of the COVID-19 pandemic. Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture.

Communication 77

Communication Biosimilars Compounding 77

Pharmaceutical Technology

NOVEMBER 29, 2022

According to PharmatTher’s November 14 press release, all 10 patients in the Phase I/II trial reported a reduction in dyskinesias after receiving ketamine. Substances in this category have an approved medical use in the US, but can result in low or moderate physical dependence or high psychological dependence.

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Pharmaceutical Companies Pharmaceutical Companies Labelling 110

Eye on FDA

APRIL 15, 2020

First, they may represent advances in either safety or efficacy over previous treatments – or they can even be bringing new treatments in a category where there are very few or no viable treatment options. Drugs coming to market are important in several respects. Recently in the U.S.

Vaccines 55

Vaccines 55

PharmaShots

MAY 10, 2023

Sports Medicine, Extremities, Trauma, Craniomaxillofacial, and Thoracic) are among the company's product categories. The company has also marked its position in the global medical device market and delivers a wide range of products under the categories Interventional Solutions, Orthopedics, Surgery, and Visions.

Nursing Homes 40

Nursing Homes Hospitals Physician Offices Diabetes 40

PharmaShots

FEBRUARY 21, 2023

The company has classified its products into three broad categories: precision diagnostics, radiopharmaceutical oncology, and strategic partnerships. Additionally, In Jun’21, Novartis received the BTD from the US FDA for Pluvicto based on the data from P-III clinical trial (VISION).

Dosage 56

Dosage Labelling Immunity Immunization 56

pharmaphorum

DECEMBER 16, 2022

New category. The PM Society is delighted to announce a brand new, free of charge, category in the PM Society Awards 2023. This category has come about from a collaboration between the PM Society, the IPA, and ISBA, in connection with the Pitch Positive Pledge campaign. PM Society Awards.

Communication 52

Communication 52

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. Category 3: Configurable Software Configurable software is customizable to some extent but does not require full software development.

Documentation 52

Documentation Dosage Labelling Data Entry 52

Putting Patients First Blog

MARCH 9, 2023

ET at the National Press Club in Washington, DC. NHC members in the business, industry, and associate categories receive one Symposium registration as a member benefit. Taking place in-person for the first time since 2019, the Symposium will be on May 8, 2023, from 8 a.m. – Who should attend?

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GMPSOP

FEBRUARY 25, 2023

Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Cases where sampling failure can become very costly Before you release pharmaceutical products for sale, it is important check the medicinal products are filled into right type of container (e.g.,

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Putting Patients First Blog

JANUARY 10, 2024

Risk Adjustment Models: The NHC recommends that CMS regularly reevaluate the HHS-Hierarchical Condition Category (HCC) risk score model to incorporate patient perspectives to ensure the model’s sensitivities to the complexities of complex conditions and accurately reflect health care costs and ensure financial stability for insurers.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Diabetes 40

The Thyroid Pharmacist

JULY 14, 2023

Additionally, researchers report that a test can be done by administering TRH (Thyroid Releasing Hormone), which will cause an increase in T3 and T4 if the thyroid has recovered. If you are looking for something that covers either a bigger area or the whole body, take a look at something in their moderate or full-size category.

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Dosage Immunity Immunization Documentation 97