The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

Drugs 52

Drugs Research FDA Approval Manufacturing 52

Pharmacy Checkers

JANUARY 10, 2020

For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” That response is related to well-made generic drugs – not those discovered as inferior due to fraud or poor manufacturing , which is a serious problem.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Pharmacy Checkers

JUNE 21, 2019

Amazon’s support for The Affordable and Safe Prescription Drug Importation Act , introduced by Senator Bernie Sanders (I-VT)—to allow for the importation of lower-cost prescription drugs—would be the game changer that would have American patients cheering and the pharmaceutical industry crying. prescription drugs. regulations.

Pharmacy 61

Pharmacy Drugs Branding Medicine 61

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. for drug safety. counterparts. J)(2) Waiver authority.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

SEPTEMBER 14, 2020

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92