The FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Labelling FDA 45

European Pharmaceutical Review

APRIL 13, 2023

For example, the relaxed attitude towards cannabis in the Netherlands is well-known and Portugal has decriminalised the possession and consumption of all illicit substances since 2001. The US Food and Drug Administration (FDA) has decided to fast-track psilocybin for depression, with full support from President Biden’s administration.

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Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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ISPE

FEBRUARY 13, 2023

While at TGA Bob also served as Deputy Chairman of PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001. He became Chief GMP Inspector in 1980 where he influenced many of the GMP requirements.

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The FDA Law Blog

FEBRUARY 19, 2023

Mr. Houck was a diversion investigator with the Drug Enforcement Administration (“DEA”) in the field and at agency headquarters for 15 years before joining HPM in 2001. at this year’s American Pharmacists Association’s (“APhA’s”) Annual Meeting in Phoenix, March 24-27.

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pharmaphorum

SEPTEMBER 13, 2022

2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. Today, the bone marrow donor registry comprises more than 39,527,166 donors and 804,246 cord blood units.

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The FDA Law Blog

MAY 3, 2023

Before joining HP&M in 2001, Mr. Houck conducted numerous scheduled cyclic and targeted inspections and investigations as a DEA Diversion Investigator in the field for ten years. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

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Controlled Substances 52

PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

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The Checkup by Singlecare

SEPTEMBER 11, 2024

Food and Drug Administration ( FDA ) to treat major depressive disorder (depression) in adults, and it is sometimes used off-label as an appetite stimulant. A 2001 clinical study found that 21% of self-reported weight gain occurred after 12 weeks of mirtazapine treatment. Why does mirtazapine cause weight gain?

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Labelling FDA 87

The FDA Law Blog

SEPTEMBER 12, 2023

In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr. Houck was a DEA Diversion Investigator for 15 years prior to joining HPM in 2001.

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European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

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The People's Pharmacy

JUNE 1, 2023

Discovered in 2001, HMPV is in the Pneumoviridae family along with respiratory syncytial virus (RSV).” ” What jumps out for me is that this virus was only “discovered” in 2001 by Dutch researchers. By the way, the FDA recently announced (May 3, 2023) that it approved an RSV vaccine ( Arexvy ).

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The FDA Law Blog

SEPTEMBER 26, 2023

In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr. Houck was a DEA Diversion Investigator for 15 years prior to joining HPM in 2001.

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Policy Prescription

MARCH 11, 2022

For the record, CanadaDrugs.com was never found or even accused of selling a counterfeit drug to its online pharmacy customers while it operated from about 2001 to 2018, but the pharmaceutical industry wanted people to believe otherwise. It seems that the appellant was also told that MHRA would notify the FDA of the situation.

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FDA 52

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. 10 Since FDA approval in 1998 the ‘Little Blue Pill’ had some of the fastest prescription uptakes and sales growth of any medication, bringing in $400 million in revenue in its first quarter after launch and going on to produce annual sales of about $1.8

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The Checkup by Singlecare

AUGUST 8, 2024

Drug shortages in the United States are extremely common, with the number of ongoing and active shortages at their highest since the American Society of Health-System Pharmacists (ASHP) began tracking in 2001. According to the FDA, manufacturing issues are the main reason for drug shortages. Many factors cause medication shortages.

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Compounding FDA Compounding Pharmacies Community Pharmacies 52

The Checkup by Singlecare

SEPTEMBER 13, 2023

In humans, metronidazole is FDA-approved for treating certain bacterial infections. Although not FDA-approved for animals, metronidazole is used off-label in cats when prescribed in veterinary medicine. What is metronidazole used for in cats? appeared first on The Checkup.

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PharmaShots

APRIL 20, 2023

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

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The FDA Law Blog

MAY 22, 2023

Before joining HP&M in 2001, Mr. Houck conducted numerous scheduled cyclic and targeted inspections and investigations as a DEA Diversion Investigator in the field for ten years. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

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Controlled Substances 40

The People's Pharmacy

MAY 22, 2023

Transient Global Amnesia: We first heard about a rare medical condition called TGA (transient global amnesia) in 2001 from a reader of this newspaper column. That said, the FDA requires this notification in the official prescribing information: “There have been rare reports of cognitive impairment (e.g., It leaves a lot of uncertainty.

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The FDA Law Blog

APRIL 23, 2023

If sponsors do not own the data used for the external control arm, they should structure agreements with the data owner to ensure that patient-level data can be provided to FDA. data on each participant and patient in the externally controlled trial), as required under FDA regulations, for both the treatment and external control arms.”

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PharmaShots

FEBRUARY 21, 2023

In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. In Jun’21, the company initiated the evaluation of FAP-2286 in a P-I/II clinical trial (LuMIERE) following the US FDA’s IND clearance. In Sep’21, the US FDA granted DUNP19 an ODD for Osteosarcoma.

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The Checkup by Singlecare

SEPTEMBER 14, 2023

Food and Drug Administration (FDA) in 2001. Nexium is chemically similar to Prilosec (omeprazole), the first PPI approved by the FDA in 1989. The FDA approved the first generic of prescription Nexium, esomeprazole , in January 2015. New brand-name drugs undergo extensive testing to be approved by the FDA.

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Policy Prescription

JANUARY 31, 2022

While the drug companies, wholesalers, pharmacies and doctors, and federal regulators, such as the FDA and DEA, all point fingers at each other , it seems that the state boards of pharmacy are getting a pass that they don’t deserve. So, where was the West Virginia Board of Pharmacy?

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The FDA Law Blog

OCTOBER 4, 2023

Engler , a 2001 decision by the Sixth Circuit Court of Appeals. While this standard is different from the standard applicable to the underlying cases, some of the analysis coincides with those cases. The Plaintiffs argued the unconstitutionality of the Medicare Negotiation Program under the Fifth Amendment by relying on Michigan Bell v.

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The Checkup by Singlecare

MARCH 28, 2024

Food and Drug Administration (FDA) in 2001 , Adderall XR has become a popular medication for managing symptoms of ADHD. It works by increasing natural substances within the brain, which may help improve the ability to focus, stay attentive, and manage behavior. Following its approval by the U.S.

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The Checkup by Singlecare

DECEMBER 13, 2023

Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting. Sources: Central neurocircuitry associated with emesis , The American Journal of Medicine (2001). It can also ease an upset stomach, diarrhea, heartburn, and indigestion. Antiemetic medications , StatPearls (2022).

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pharmaphorum

SEPTEMBER 18, 2020

In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide). Between 2001 and 2005, Nexium netted AstraZeneca approximately $14.4 However, this new name has since caused confusion between Prilosec and Prozac.

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ISPE

JULY 10, 2023

For example, ISO 8 required 20 to 30 air changes in 2001 when Federal Standard 209E was withdrawn. Proceedings of the 2001 ACEEE Summer Study on Energy Efficiency in Industry. American Council for an Energy-Efficient Economy, Washington, DC, 2001. Now most guidance for ISO 8 suggests 10 to 20 air changes per hour (ACH).

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The Spirit Pharmacist

FEBRUARY 21, 2023

The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. Neurotoxicol Teratol, 2001. How Do Psychedelics Compare to Current Treatment Options? There are a couple notable advantages [1]. Clin Obstet Gynecol, 2019.

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PharmaShots

FEBRUARY 20, 2023

These guidelines are largely specified by the European Commission (EC) in Directive 2001/83/EC and Regulation (EC) No 726/2004. Protalix, developed Elelyso/UPLYSO by using its ProCellEx platform that received approval in May 2012 from the US FDA and being used for the treatment of Type 1 Gaucher disease 6.

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The Checkup by Singlecare

SEPTEMBER 19, 2024

Food and Drug Administration (FDA) for pain treatment, not sleep disorders. According to a European Journal of Anesthesiology 2001 study, researchers found that “people who took tramadol had less stage four restful REM sleep and woke up feeling more tired,” says Dr. Hendricks. Tramadol is only approved by the U.S.

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The Checkup by Singlecare

OCTOBER 3, 2023

It is approved by the Food and Drug Administration (FDA) for treating major depressive disorder. In addition to the treatment of depression, bupropion is available under the brand name Zyban, which has been FDA approved as a smoking cessation medication. What can I take in place of Wellbutrin?

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ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

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Pharmacy Friday Pearls

MARCH 9, 2022

It is important to note that at present, Anavip ® is only FDA approved for North American rattlesnake envenomations, even though it is expected that it is safe and effective to use for copperhead and water moccasin envenomations as well. in the treatment group vs 7.4 in the control group (95% CI 0.1 – 2.3;

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Druggist

FEBRUARY 10, 2021

In the US, the Federal Drug Administration (FDA) reported serious, statin-caused liver disease as extremely rare (ibid). 2001 Sep;12(5):565-9. The frequency of statin-related myopathy (muscle pain, muscle weakness, cramps and tendon pain) was found to be slightly higher. per 10,000 person-years (Gaist et al., Can statins cause stroke?

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Community Pharmacies FDA 52

The Checkup by Singlecare

JANUARY 12, 2024

The FDA extended warning for intravenous haloperidol and torsades de pointes: how should institutions respond? Benzyl alcohol, kernicterus, and unbound bilirubin , Journal of Pediatrics (2001). Cleveland Clinic (2023). Journal of hospital medicine (2010). Phenylketonuria. Mayo Clinic (2022).

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