Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist. in November 2009.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

Syner-G

AUGUST 9, 2022

IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity.

Labelling 40

Labelling Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up.

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

Eye on FDA

JULY 7, 2020

The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter. This item disappeared from the agenda, however, and no draft guidance was issued.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

Pharmaceutical Technology

OCTOBER 5, 2008

“The business integration from 2005 to 2007 of the two separate companies to form the joint Daiichi Sankyo created one of Japan’s biggest pharmaceutical companies.” Like in many other sectors, China and India are the ones labelled as those which will lead the expansion.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 40

PharmaShots

FEBRUARY 21, 2023

The company expects to commence P-I clinical trials on metastatic and pediatric primary bone cancer patients. FAP-2286 (labeled with lutetium-177), a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP), is the company’s lead asset amongst radiopharma products.

Dosage 56

Dosage Labelling Immunity Immunization 56

PharmaShots

APRIL 13, 2023

model is a holistic approach to incorporate the same strategy to life science and pharmaceutical companies. A globally fast-growing, and largest pharmaceutical company in the world was created through a merger between Pfizer and Pharmacia. Model: Inspired by the industry 4.0 model, the pharma 4.0

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40