Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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. % in India.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 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. FDA said they would produce a guidance by the end of 2010, but did not.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. Prior to joining Fieldfisher, Taly spent four years working as in-house counsel for a leading tech company helping launch products across multiple EU markets. 2010 [cited 2024May].

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

PharmaState Academy

OCTOBER 25, 2023

a) 1995 b) 2000 c) 2010 d) 2015 5 / 20 In the United States, what is the maximum time period allowed by the FDA for a pharmaceutical company to respond to an unsolicited request for off-label information from an HCP?

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Labelling 52

PharmaShots

FEBRUARY 21, 2023

Market Cap: $10.67M Founded Year: 2009 Total Employees: ~410 Headquarters: Colorado, United States Stock Exchange: OTCMKTS Clovis Oncology is a biopharma company that develops and delivers anti-cancer agents to the US, EU, and other international markets.

Dosage 56

Dosage Labelling Immunity Immunization 56

The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” link] Published March 2010. thingsIlearnedthehardway). J Fungi (Basel).

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105