Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

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Pharma in Brief

DECEMBER 23, 2021

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. The amendments to the Regulations contain a number of changes affecting the PMPRB’s review of patented medicine prices. The amendments.

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Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.

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STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. Food and Drug Administration and the U.S. As for us, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is a Mardi Gras blend. And how is your morning going? To help you along, here are some tidbits.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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Pharma in Brief

AUGUST 5, 2020

DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA. Because DESCOVY contains TAF, it benefits from the same data protection term granted to GENVOYA. Background.

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WCG Clinical

DECEMBER 13, 2023

These supplements are not classified as drugs under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and, as such, do not require pre-marketing approval from the U.S. Food and Drug Administration (FDA). Dietary supplements are easily accessible on store shelves or online marketplaces. What Is a Dietary Supplement?

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FDA Law Blog

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.

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FDA Law Blog

JULY 7, 2022

While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics. a requirement for FDA to issue regulations to establish standardized testing methods for detecting and identifying asbestos in talc-containing products.

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XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Compared to the drug approval side of the FDA, the food safety and nutrition divisions are chronically underfunded.

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Medical Xpress

DECEMBER 2, 2022

Cough medicines containing the chemical pholcodine should be banned due to the risk of potentially deadly allergic reactions in people under general anaesthetic, the European Union's drug regulator said Friday.

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Pharmaceutical Technology

MAY 9, 2023

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet.

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pharmaphorum

SEPTEMBER 2, 2020

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury. In July, Gilead’s Veklury (remdesivir) became the first drug cleared by EU regulators to treat symptoms in patients hospitalised with COVID-19.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Continued authorization for COVID-19 drugs.

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FDA Law Blog

JANUARY 3, 2024

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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BioSpace

JANUARY 5, 2023

The regulator says drug compounders are selling products that falsely claim to contain the same active ingredient, semaglutide, as the blockbuster diabetes and obesity drugs.

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Pharma in Brief

OCTOBER 29, 2020

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

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Pharma in Brief

JANUARY 18, 2021

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

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STAT News

MARCH 1, 2023

A government watchdog found that Medicare drug plans improperly authorized thousands of prescriptions for certain powerful opioids over a recent four-year period, a failure that cost taxpayers $86 million as the opioid crisis was raging across the U.S. The opioids were approved by U.S. Continue to STAT+ to read the full story…

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Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Health Canada has also updated its fee for CSP applications.

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FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. In fact, federal law and regulation appear to require AbbVie to list these patents.”

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Scienmag

DECEMBER 9, 2021

When the body attempts to fight off an infection, immune cells called neutrophils may shoot out spider web-like networks of toxic proteins to help contain the invaders.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. the PMS Product ). In that case, Manson J. Knowledge of influence.

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Pharma in Brief

JULY 28, 2020

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations ( CSP Regulations ). 2,606,282 ( 282 Patent ) and the drug JULUCA ® ( Decision ). The 282 Patent contains claims directed to dolutegravir, one of the medicinal ingredients in JULUCA.

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FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. OTC products are also susceptible; testing has revealed nitrosamines in heartburn remedies containing ranitidine.

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Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Regulators are well-disposed to these boosters. Although the UK has fewer facilities, around 70% of those offer dose manufacturing with containment.

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FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. mL strength pre-filled syringe). mL pre-filled syringe.

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FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. the nanotube—is irrelevant, as it is the “active ingredient” that matters for purposes of classifying the product as a drug or biologic.

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Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

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FDA Law Blog

AUGUST 21, 2023

During a routine inspection in June 2022, Drug Enforcement Administration (“DEA”) diversion investigators determined that People’s Rx pharmacy violated recordkeeping requirements, improperly dispensed controlled substances to practitioners for office stock and issued prescriptions without authorization. 16, 2023 ( DOJ Press Release ).

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XTalks

MARCH 22, 2024

According to the EWG, about 95 percent of nonorganic strawberries, certain leafy greens (including spinach, kale, collard and mustard greens), grapes, peaches and pears contain detectable levels of pesticides. The USDA and US Food and Drug Administration (FDA) test produce for pesticides.

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FDA Law Blog

MAY 3, 2023

the regulations formerly found in 21 C.F.R. The initial group posted also included the administrative order containing a list of certain active ingredients offered for certain OTC uses FDA had found to be non-monograph conditions (former 21 CFR § 310.545). All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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