The FDA Law Blog

DECEMBER 21, 2023

In other exciting news — in 2024 FDLI will be getting a make-over! Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). Mark your calendars now.

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FDA 59

pharmaphorum

MAY 26, 2021

Campaign group Just Treatment, with the help of legal firm Foxglove, has sent a letter to the Department of Health and Social Care questioning the lawfulness of the plan, such as the short six-week opt-out period which gives people limited time to consider the changes. For news on this case, sign up here: [link].

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Communication Pharmaceutical Companies Pharmaceutical Companies Vaccines 115

The Checkup by Singlecare

DECEMBER 4, 2023

Coming off the COVID-19 pandemic, 2023 was a much more normal year of health news. Through it all, we provided informative health and wellness news on a range of topics, such as nutrition advice, how to manage weight loss medications, and tips for safely buying prescription drugs in other countries. Read the full article here.

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Insurance 105

Pharmaceutical Technology

MARCH 23, 2023

The new framework will introduce a legal mandate to register a trial in the World Health Organisation (WHO) public register. The news arrives after a 2022 The Association of the British Pharmaceutical Industry (ABPI) report said the UK’s collapsing clinical research industry was collapsing.

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pharmaphorum

MAY 24, 2021

“This is good news, because the success of digital applications depends to a large extent on their acceptance,” added Sturm. Before the legal changes, these were reimbursed on a case-by-case basis. The survey found 46% of US respondents, 56% of Germans and 60% of Spanish people share this opinion.

Medical Records 144

Medical Records 144

STAT

DECEMBER 5, 2022

… Johnson & Johnson said it does not intend to make an offer for Horizon Therapeutics, days after the developer of medicines for rare autoimmune and inflammatory diseases revealed it was in talks with the company , Bloomberg News writes. regulatory approval, Bloomberg News says.

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FDA 52

The FDA Law Blog

NOVEMBER 7, 2023

Mass hysteria! ” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. Koblitz — “ Human sacrifice! Dogs and cats living together! And this is the first inkling we have about the government’s position.

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FDA Dosage 59

European Pharmaceutical Review

JANUARY 25, 2023

Enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution and/or use of substandard and falsified medicines. NEWS: What can we learn from contamination control failures?

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The FDA Law Blog

SEPTEMBER 11, 2023

As a reminder, devices with preamendment status are those that were legally marketed in the US before May 28, 1976, have not been significantly changed since May 28, 1976, and for which a regulation requiring a premarket approval application has not been published.

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Documentation FDA 64

pharmaphorum

DECEMBER 15, 2022

Here are the key details of those appointments: ADC Therapeutics (makers of antibody-drug conjugates starting with Zynlonta) appointed Kristen Harrington-Smith as chief commercial officer and Peter Graham as chief legal officer. Dier (replacing Gil Labrucherie ) and chief legal and administrative officer Mina Kim.

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Immunization Vaccines 52

IDStewardship

OCTOBER 28, 2022

Since the news of virtual Midyear in 2020, many residency programs have created social media accounts, most often on the platform Twitter. Circumventing these policies by using your personal account as a substitute is not recommended and could result in legal action against you. . I have got you covered! BMCPharmRes. MUSCPharmRes.

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Documentation 229

pharmaphorum

JUNE 18, 2021

The court judgment ordering AstraZeneca to deliver to us rapidly 50 million doses is good news for our vaccination campaign. It is also a clear recognition that our Advance Purchase Agreements have a sound legal basis. Good results for Europe! Our vaccines strategy delivers. — Ursula von der Leyen (@vonderleyen) June 18, 2021.

Vaccines 58

Vaccines 58

Omnicell

JANUARY 10, 2023

Depending upon the manufacturer's reason for withholding 340B pricing, you could be entitled to future compensation via legal action or the administrative dispute resolution (ADR) process. But the good news is that the issue can be remedied. They may simply require a little more effort to create an auditable record.

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Omnicell Hospitals Documentation 40

Digital Pharmacist

OCTOBER 5, 2022

Any US citizen or legal permanent resident over the age of 65 can apply for Medicare Open Enrollment. . This includes sharing newsletters, blog posts, news articles, and social media posts that tell patients about their Medicare plan options. This leaves very little time before patients need to re-evaluate their insurance. .

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Independent Pharmacies Insurance Nursing Homes Hospitals 98

Pharmaceutical Technology

MAY 9, 2023

As per Stat News , the Canadian company BTNX plans to sell xylazine strips at $200 for a box of 100 strips. “To “The research on fentanyl test strips shows that people will use them when they perceive themselves at risk, and then practise safer consumption behaviours to reduce risk and increase locus of control.”

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Controlled Substances FDA 111

European Pharmaceutical Review

AUGUST 26, 2022

“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” added Moderna’s Chief Legal Officer, Shannon Thyme Klinger.

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Vaccines Immunization 94

The Checkup by Singlecare

MARCH 7, 2024

The good news is that many Medicare prescription plans may help pay for Ozempic, although it may depend on the reason for taking it. These pharmacies are perfectly legal and may help save money. With such skyrocketing popularity, Americans looking to get their hands on Ozempic might wonder whether they’ll be able to afford it.

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Compounding Pharmacies Insurance Insurance Coverage Compounding 93

pharmaphorum

JULY 21, 2021

News of the proposed deal stems from an Associated Press report , which cites people close to the legal process and says that each state has to agree to the terms. New York has already agreed to its own deal, a $1.1

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Packaging 52

The FDA Law Blog

MAY 9, 2023

The news wasn’t all bad for the government, but FTC’s now has some decisions to make. Deceptive practices are the frequent bedrock legal theory for these cases. The rest of Khan’s week didn’t go as well. Back in the Summer of 2022, FTC approached Kochava about its contemplated suit against the company for violations of the FTC Act.

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FDA 59

The FDA Law Blog

SEPTEMBER 19, 2023

Thus, “FTC intends to use its full legal authority” to take action “against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.” Hopefully, we’ll see the further direction that industry has been seeking for almost 20 years in the near future.

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FDA Communication Dosage 105

The Checkup by Singlecare

MARCH 21, 2024

In this article, we’ll cover how much some have saved, if this method is safe and legal, and the issues with U.S. The good news is that there are several ways to get discounted Ozempic without crossing the border. While there are several ways to save on Ozempic, U.S. citizens crossing the border for Ozempic.

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Insurance Coverage Insurance Dosage Mail-Order Pharmacies 98

European Pharmaceutical Review

NOVEMBER 30, 2023

NEWS: Biopharma struggling to find talent with adequate digital skills Looking onward to 2028, the Skills report predicted that, out of a total 81 percent within the cell and gene therapy industry, roles will span support services, R&D and discovery, and bioprocessing.

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Medical Schools 82

The Checkup by Singlecare

OCTOBER 11, 2023

Food & Drug Administration (2023) Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine , U.S. Be aware that oxymetazoline-based decongestants if used for more than three consecutive days causes rebound congestion.

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Mayo Clinic Immunization FDA Compounding 106

pharmaphorum

DECEMBER 2, 2020

The news of this disastrous result came days after CEO Jeff Kindler had hailed the drug as potentially “one of the most important compounds of our generation”. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag. Likewise, tanezumab, an anti-osteoarthritic, failed in trials.

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Compounding Vaccines Pharmaceutical Companies Pharmaceutical Companies 128

The FDA Law Blog

JULY 10, 2023

If the submission passes the acceptance review, the firm will receive the first good news from FDA via email that the submission has been accepted for substantive review. The SI communication could be great news for the firm if FDA notifies that it will continue to resolve any outstanding deficiencies via Interactive Review.

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FDA Documentation Packaging Communication 75

DiversifyRx

APRIL 27, 2023

3 Provide Prescribing Cheat Sheets News flash… doctors have egos! At least the doctor or patient will know you aren’t being rigid to suit yourself, but there is a clinical/legal/practical reason why. TIP: Pharmacy Badass University members, submit your custom marketing requests, and we will make your flyers for you! #3

Compounding Pharmacies 52

Compounding Pharmacies Compounding Independent Pharmacies Packaging 52

Hospital Pharmacy Europe

AUGUST 22, 2023

During this time, drugs such as anti-epileptics and anti-depressants were headline news, particularly the high level of reports of suicidal ideation with selective serotonin reuptake inhibitors. Consequently, he became the government’s representative who undertook the necessary pharmacovigilance studies to fulfil this legal requirement.

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Vaccines Community Pharmacies Hospitals Communication 96

STAT

OCTOBER 3, 2023

product liability lawsuits related to the heartburn and stomach acid treatments Nexium and Prilosec, which some users said caused kidney damage , Bloomberg News says. The  The settlement resolves litigation in New Jersey and Delaware courts. AstraZeneca agreed to pay $425 million to settle U.S.

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The Digital Apothecary

AUGUST 15, 2017

Ever since Christina Farr of CNBC broke the news of Amazon expressing an interest of getting into the Billion Dollar Pharmacy market, I have been having multiple conversations with many people inside and outside of pharmacy on how this will change "everything." Second, along with some of these issues, is the regulatory laws in place.

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Mail-Order Pharmacies Health and Personal Care Stores Insurance Medication Dispensing 52

ISPE

MAY 10, 2023

2 Such obligatory safety features, legal framework, and record-keeping requirements have arguably imposed stricter controls for manufacturing of medicaments. link] 6 BBC News. 6 (Note: The terms “pharmaceutical” and “pharma” interchangeably employ throughout this article.) 30 June 2016. Published 19 January 2017. link] 7 He, J.,

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Dosage Chemotherapy Documentation Labelling 52

STAT

DECEMBER 13, 2023

WASHINGTON — The Supreme Court agreed Wednesday to take on whether Americans can access a commonly used abortion pill. It will be the court’s first major abortion case since it overturned Roe v. Wade last year, giving jurisdiction over abortion laws back to the states.

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FDA 118

ISPE

SEPTEMBER 11, 2023

Genetic Engineering and Biotechnology News. www.prnewswire.com/news-releases/worldwide-modular-facilities-in-pharmaceutical-and-biotechnology-industry-to-2030 impact-analysis-of-covid-19-301332565.html Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” Genentech’s New Oceanside Manufacturing Facility.”

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Health and Personal Care Stores Vaccines Packaging Documentation 52

The Checkup by Singlecare

JANUARY 18, 2024

As you seek new employment, it’s vital to find supplemental insurance until you land a new role. The good news is that you have several coverage options to choose from. citizenship or legal residency. Why do I need health insurance? Unable to access affordable coverage through an employer. Have proof of U.S.

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Insurance Insurance Coverage Packaging Hospitals 52

STAT

AUGUST 16, 2023

A federal appeals court on Wednesday ruled to restrict access to the abortion pill mifepristone but not remove it from the market entirely, partially upholding a lower court’s decision. The decision from the three-judge panel of the 5th U.S. Circuit Court of Appeals would effectively block mail-order prescriptions of the pill.

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STAT

APRIL 14, 2023

Access to the abortion pill mifepristone will remain unchanged until next Wednesday, after a U.S. Supreme Court justice on Friday issued a stay on last week’s ruling from a conservative Texas judge banning the medicine.

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FDA 98

ISPE

AUGUST 29, 2022

The timing and data requirements vary depending on the reporting category, submission, and legal obligations in each individual jurisdiction. Currently, the EU legal framework does not recognize the product life-cycle management (PLCM) document, which contains ECs and proposed reporting categories but does recognize PACMPs.

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Documentation FDA Communication Packaging 52

pharmaphorum

MAY 26, 2022

The co-founder of Los Angeles biotech Enochian Biosciences has been arrested in connection with a federal investigation into the murder of a Vermont man in 2018.

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Chemotherapy 105