pharmaphorum

JANUARY 4, 2022

They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

Documentation 52

Documentation Communication FDA 52

Omnicell

JANUARY 10, 2023

2003: Congress passed the Medicare Modernization Act (MMA), which included the creation of the Medicare Part D program. The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 2, 2022

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published 2003. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns. European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 5 (2003): 395–413. You may unsubscribe from these ISPE communications at any time.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 You may unsubscribe from these ISPE communications at any time. m/s up to 0.54 link] 9 a b Mason, W.,

Documentation 52

Documentation FDA Packaging Communication 52