pharmaphorum

DECEMBER 6, 2022

Unfortunately, he continued, “the clinical trial industry is stuck in the financial equivalent of writing cheques to people and taking your cheque book to the bank to update your balance.”. When I first started working in clinical trials, people were just moving from paper documentation to EDCs,” Peleg says.

Data Entry 98

Data Entry Communication Hospitals Documentation 98

ISPE

SEPTEMBER 12, 2022

FDA/CBER/OMPT/OCBQ. And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. Director, Office of Pharmaceutical Quality Operations. 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor. Rick Friedman. Brooke Higgins. Robert Sausville.

FDA 52

FDA Documentation Communication 52

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. Where the generic sponsor has carved-out the specific indication identified in the Orange Book as covered by the method of use patent, the Government argues, the generic labeling “cannot provide the requisite evidence of specific intent to induce infringement.”

Labelling 72

Labelling FDA Documentation Communication 72

pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. Secondary packagers.

Packaging 52

Packaging FDA Documentation Vaccines 52

The Thyroid Pharmacist

JULY 14, 2023

Here’s an excerpt from my book, Hashimoto’s Protocol : Most physicians and endocrinologists will say that in Hashimoto’s, hypothyroidism is irreversible and ends with complete thyroid cell damage, leading to a lifelong requirement of thyroid hormone medications. They may also help with circulation, skin healing, inflammation, and more!

Dosage 98

Dosage FDA Immunization Documentation 98

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.

Vaccines 128

Vaccines FDA Research Laboratories Documentation 128

The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Feel free to use my own health timeline as a guideline to document your health journey. The Environmental Working Group (EWG) also has consumer resources that can help individuals source cleaner options. As always, I wish you all the best!

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

The Thyroid Pharmacist

JUNE 14, 2023

I encourage you to take a look at my book Hashimoto’s: The Root Cause for more information on possible triggers. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! But, there are a few root causes that may be specific to men and shouldn’t be ignored.

Health and Personal Care Stores 111

Health and Personal Care Stores Immunization Documentation Compounding 111

The Thyroid Pharmacist

FEBRUARY 10, 2023

You can learn more about this in my book, Adrenal Transformation Protocol. After doing the targeted interventions outlined in my adrenal program and book, many of my clients have reported feeling more like “themselves” and even see major improvements in symptoms that had been with them for decades, in just two to four weeks.

Documentation 98

Documentation Dosage FDA Communication 98

The FDA Law Blog

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

FDA 59

FDA Documentation Packaging 59

The Thyroid Pharmacist

JANUARY 20, 2023

It has been 10 years since I wrote my first book on Hashimoto’s, yet at the time of writing, there was no “official research” to connect stress to Hashimoto’s and hypothyroidism. I love using adrenal adaptogens, especially during my own peak periods of stress (did someone say, “holidays” or “book deadline”?)

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Immunization Compounding Documentation 98