Omnicell

JANUARY 10, 2023

2011: The Government Accountability Office (GAO) published a study entitled: "Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement." Also, in 2011, the U.S. However, lawmakers decided that it was not needed anymore since HRSA was expanding the program on its own.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

The FDA Law Blog

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” However, the Government’s suggestion that the facts will be similar across skinny label cases is flatly denied by GSK in the pleadings.

Labelling 72

Labelling FDA Documentation Communication 72

European Pharmaceutical Review

SEPTEMBER 13, 2023

As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe.

Communication 72

Communication Documentation 72

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

SEPTEMBER 11, 2023

Nature Communications 12, no. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J. 22 March 2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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. Directive 2011/62/EU of the European Parliament and of the Council.” Published 2011.

Dosage 52

Dosage Chemotherapy Documentation Labelling 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 December 2011. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns.

Vaccines 97

Vaccines Compounding Documentation FDA 97