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 96

Communication Documentation 96

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 Omnicell Insurance Documentation 96

Pharmaceutical Technology

JANUARY 6, 2023

This class-action litigation specifically focused on a 2011 licensing agreement between the two companies. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”.

Documentation 97

Documentation FDA Hospitals Dosage 97

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

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.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. You may unsubscribe from these ISPE communications at any time.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

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