FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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Camargo

DECEMBER 9, 2020

Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product. The pharma industry has had meetings with the FDA for new drugs, biologics, and devices for decades. GDUFA has changed this picture, at least for complex drug products.

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Pharmacy Checkers

FEBRUARY 14, 2020

pharmacies is manufactured and sold in Canada as well. Wellbutrin XL is sold in other countries besides Canada, although we would like to point out that one PharmacyChecker-accredited international pharmacy’s website notes that it’s manufactured by GlaxoSmithKline. Comparing Wellbutrin XL Costs & Manufacturing in the U.S.

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The Pharma Data

MAY 17, 2021

As examples, the authors cited remdesivir – formerly an unsuccessful Ebola drug – and dexamethasone – a generic drug widely available for decades – being repurposed as COVID-19 treatments. After 5 years, the median number of manufacturers of 8 UDI-approved self-administered drugs decreased from 5.5

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John wanted to know if these prices were for the “same” drug. and arguably just as safe. requirements.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v). FDA regulations, at 21 C.F.R.

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Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. 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.

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Pharma in Brief

AUGUST 9, 2021

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

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Pharma in Brief

JANUARY 9, 2022

Meanwhile, the Ontario Superior Court released two decisions dismissing claims made by a generic manufacturer under the Ontario and English Statutes of Monopolies , and common law causes of actions. Health Canada also consulted on proposed guidelines for the use of electronic media in prescription drug labelling (see here ).

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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.

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Drug Patent Watch

MARCH 25, 2025

Breaking into the Generic Drug Market: Strategies for Success As a pharmaceutical professional, you know that the generic drug market is a highly competitive space. With new generic drugs entering the market every year, it can be challenging to stand out from the crowd and achieve success.

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Drug Patent Watch

FEBRUARY 17, 2025

Unlocking the Path to Affordable Medications: A Step-by-Step Guide to Generic Drug Approval As a healthcare professional or a patient advocate, you're likely no stranger to the importance of affordable medications. But have you ever wondered what it takes for a generic drug to hit the market?

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XTalks

JANUARY 23, 2025

In its second interim staff report released January 14, 2025, the Federal Trade Commission (FTC) revealed that the top three pharma benefit managers (PBM) in the US inflated prices of specialty generic drugs over the past several years, resulting in them raking in billions of dollars in profits. What Is a PBM? billion in 2021.

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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.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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Pharmacy Checkers

OCTOBER 11, 2019

It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public. The discussion below applies to brand-name (not generic) drugs. Drug companies make their products in many countries and ship those same drugs around the world to different markets.

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Pharmacy Checkers

MARCH 11, 2020

Postal Service for packages coming through IMFs. [16]. That AED lets the USPS know the source of a package. Thus, for example, the path of a drug from a licensed pharmacy in Canada to a patient in the U.S. Personal Drug Importation Related to the Internet. could be guaranteed using AED.

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FDA Law Blog

SEPTEMBER 13, 2021

A final rule to establish a Most Favored Nation model to base Medicare drug payment on international prices was enjoined by two federal courts, and HHS recently proposed to rescind the rule (see our post here ). The pieces of major drug pricing and payment reform are falling together. Court of Appeals (again, see our post ).

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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.

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