The FDA Law Blog

JANUARY 18, 2024

Last November, FDA published a notice of a proposal to withdraw approval of the three carbadox New Animal Drug Applications (“NADAs”) under 21 U.S.C. FDA now says that this long prologue put Phibro on notice that its bacon was close to the fire. Specifically, FDA is looking to remove a drug called carbadox from the market.

FDA 59

FDA Communication 59

The FDA Law Blog

SEPTEMBER 28, 2023

The facts of Marschall’s case do not make a particularly compelling vehicle for the important legal question of whether a person can be convicted of a felony without any evidence of knowledge or intent. Under Marschall , this corporate entity was on notice.

FDA 52

FDA Labelling 52

Pharma Marketing Network

JULY 26, 2023

However, in recent years, there has been a noticeable decline in the number of these letters being issued. They have invested in compliance training for their marketing teams, adopted sophisticated review processes, and sought external legal counsel to ensure adherence to FDA regulations.

FDA 97

FDA Pharmaceutical Companies Pharmaceutical Companies Labelling 97

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

Compounding 111

Compounding Controlled Substances FDA Patient Care 111

pharmaphorum

MAY 26, 2021

Added to that, the bloc’s legal team is looking for an additional penalty of €10 million for each breach of the contract decided by the judge in the lawsuit, although that isn’t due to come under consideration until later this year. He also claimed that AZ had failed in its duty to provide timely notice of the supply problems.

Vaccines 78

Vaccines 78

The FDA Law Blog

MARCH 11, 2024

The Agency’s action to rescind this 510(k) is based on questionable legal authority. FDA does not have the same regulatory or legal authority to rescind a 510(k) for unreliable non-clinical data unless such data is the result of misconduct. On behalf of Nautilus Gloves LLC (Nautilus), link ). 812.119(e).

FDA 64

FDA Communication 64

Hospital Pharmacy Europe

OCTOBER 30, 2023

With any medicines bought outside of the legal supply chain, the contents may not match the ingredients on the label.‘ All pharmacists are therefore asked to check all primary packaging for authenticity before dispensing the medicine to patients until further notice,‘ it said.

Labelling 52

Labelling Packaging Hospitals 52

InCrowd

JUNE 12, 2023

After taking report, I noticed the legal name attached to her medical record was not consistent with what I perceived as her gender expression. I had a patient in the ICU who was recovering from a serious infection.

Medical Records 52

Medical Records Compounding 52

The FDA Law Blog

FEBRUARY 5, 2023

The court refused to give separate legal significance to the fact that HRSA withdrew the proposed rule in 2017 and found a 30-day notice period before the final rule was sufficient under the Administrative Procedures Act. The court also reviewed HRSA’s dispute resolution rule and a majority of the judges upheld it.

52

52

The FDA Law Blog

JUNE 16, 2023

The ambiguity in this critical term makes it impossible for manufacturers to know how much they can increase prices without incurring severe penalties, and leaves the law vulnerable to legal challenge for unconstitutional vagueness.

Dosage 45

Dosage Documentation Labelling 45

pharmaphorum

JULY 21, 2022

If businesses have received a notice of inspection, they should focus on two key things: Adulteration: proof there is no chemical, microbial, viral, or other type of contamination in products. Sites should ensure they are compliant across the key areas of concern outlined by the FDA and inspect their sites against this.

FDA 95

FDA Pharmaceutical Companies Pharmaceutical Companies 95

The FDA Law Blog

MARCH 12, 2024

Failing to list the patents, as AstraZeneca points out, “may expose the reference drug sponsor to legal risks,” as “at least one generic applicant has argued that a failure to do so constitutes a violation of the antitrust laws by depriving the applicant of information that would have affected its decision whether to develop a generic product.”

Dosage 59

Dosage FDA 59

The FDA Law Blog

JUNE 11, 2023

The Federal Register notice notes that “[c]ombining discussion of PREA and the BPCA together in regulatory guidance emphasizes the sponsor’s need to consider both laws when developing pediatric drugs and biological products.”

Labelling 40

Labelling FDA 40

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.”

FDA 105

FDA Communication Dosage 105

The FDA Law Blog

AUGUST 4, 2023

DEA must also transmit the notice of a proposed order to HHS and take into consideration comments from that agency. The final rule does not change the legal status of the anabolic steroids. The temporary scheduling cannot take effect until 30 days after publication in the Federal Register. at 50,041 codified at 21 C.F.R.

Controlled Substances 52

Controlled Substances Labelling 52

The Checkup by Singlecare

FEBRUARY 15, 2024

Have you ever noticed those well-behaved dogs walking through the grocery store or perhaps an airport, wearing a red vest and heeling perfectly alongside their owner? The chances are the dogs you’ve seen are service animals. There are an estimated 500,000 service dogs in the United States.

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

DiversifyRx

APRIL 27, 2023

Unless you have been hiding under a rock, you have probably noticed that weight loss drugs are a hot topic. 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.

Compounding Pharmacies 52

Compounding Pharmacies Compounding Independent Pharmacies Packaging 52

The FDA Law Blog

APRIL 30, 2023

by receiving a Paragraph IV notice) nonetheless might remain in the dark because a particular application references a different RLD or lacks a Paragraph IV certification. Indeed, that appears to be the precise objective of these provisions in S.

Immunization 59

Immunization FDA Labelling 59

The FDA Law Blog

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product.

FDA 115

FDA Documentation 115

The Thyroid Pharmacist

APRIL 28, 2023

Interestingly, this was a symptom mainly noticed by men, who reported feeling weaker and less athletic, in contrast to women, who were more likely to notice excess weight gain and feel more “squishy.” You’ll notice that magnesium is also listed as an electrolyte. A simple hack to remain alkaline (i.e.

Immunization 94

Immunization Dosage Compounding Communication 94

The Checkup by Singlecare

JANUARY 18, 2024

Your employer will provide you with the COBRA Election Notice , which includes detailed instructions on how to apply for coverage within 45 days of losing your job. citizenship or legal residency. “However, you’re now required to pay for the entire monthly premium, including the amount the employer had been paying.” Have proof of U.S.

Insurance 52

Insurance Insurance Coverage Packaging Hospitals 52

The FDA Law Blog

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. 1395w-114c(d), CMS will allow participating manufacturers to audit the TPA up to one time per year with at least a 60-day notice. Final Guidance at 15.

Labelling 105

Labelling Compounding Payment Processing Vaccines 105

STAT

AUGUST 11, 2023

As demand for Ozempic and Wegovy surges, a little-noticed warning about the medicines was issued recently by the U.S. The arrangement would provide immunity for the Sacklers in exchange for a contribution of up to $6 billion to the proposed settlement. Food and Drug Administration , STAT notes.

Compounding 98

Compounding Immunization 98

The FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

FDA 81

FDA Hospitals Immunization 81

Pharmaceutical Technology

MAY 24, 2023

Whilst the pharma industry has been relatively slow in developing new treatments – an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis still trundles on. The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US.

FDA 59

FDA 59

The FDA Law Blog

FEBRUARY 20, 2023

FTC and DOJ have for years developed cases under the legal theory that lax data privacy policies amount to unfair and deceptive acts and practices and thus are violations of the FTC Act. Perhaps these terms are severe to GoodRx, but the civil penalty was noticeably small compared to other FTC data privacy cases. The penalty of $1.5

FDA 105

FDA HIPAA 105

Druggist

JANUARY 9, 2021

Legally, In the pharmacy customers can buy up to 100 tablets or capsules without a prescription. Some noticeable side effects are named as ‘ triptan sensations ‘ and may include: Flushing. Is paracetamol effective painkiller for migraine? Tingling sensation.

Packaging 98

Packaging 98

The FDA Law Blog

SEPTEMBER 15, 2022

For OTC drug products, this guidance (simply) restates the legal requirements included in regulations regarding the quantitative information for sodium and potassium in labeling of OTC products intended for oral ingestion.

Labelling 45

Labelling FDA 45

The FDA Law Blog

OCTOBER 6, 2023

Part 803 and notices of correction and removal under 21 C.F.R. Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation. Stage 2 (two years after issuance of the final rule) : Register with FDA as a device establishment and list LDTs performed, pursuant to 21 C.F.R.

FDA 64

FDA Labelling 64

The FDA Law Blog

JANUARY 8, 2023

The report must also discuss the barriers associated with conducting research with cannabis and CBD in states that have legalized their use, how barriers might be overcome and whether public-private partnerships or federal-state partnerships can or should provide researchers with additional cannabis and CBD strains. 21 U.S.C. §

Controlled Substances 64

Controlled Substances Inventory Control Compounding FDA 64

The FDA Law Blog

NOVEMBER 14, 2022

Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). Specifically, the guidance states that FDA considers overpackaging to be the enclosure of individual drug products that each bear full and complete labeling information required under the FDC Act to allow legal marketing individually.

FDA 52

FDA Packaging Labelling Dosage 52

DiversifyRx

MAY 3, 2023

An expert can: Help you identify and solve problems you may have yet to notice. RJ Hedges: Jeff Hedges and his team are masterful experts at helping independent pharmacies meet legal compliance in many areas. An expert can be a fresh perspective, experience, and knowledge to take your pharmacy to the next level.

Independent Pharmacies 52

Independent Pharmacies Communication 52

The Physician Pharmacist

OCTOBER 5, 2023

And you obviously obviously started your financial pharmacist to what what we As your motivation for starting the business itself, so you wrote the book and everything is just kind of what I've noticed, especially with my own business is that you kind of you start with one idea, and then you progress it, it all starts to roll together.

Medical Schools 52

Medical Schools Insurance Independent Pharmacies Compounding 52

pharmaphorum

JANUARY 22, 2021

The 510(k) process already gave considerable regulatory leeway for new products, allowing the FDA to wave products through to market that it found to be “substantially equivalent” to another legally marketed predecessor. The team from Hogan Lovells said that the exemptions remain in place for seven of the devices, all of which are gloves.

FDA 80

FDA 80

Omnicell

JANUARY 10, 2023

Ted Slafsky Founder and Principal, Wexford Solutions, and Publisher and CEO, 340B Report These days, it seems like we need the help of a professional juggler to keep up with the developments in the various legal cases surrounding the 340B compliance & legislation.

Hospitals 52

Hospitals Patient Care 52

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.

Documentation 52

Documentation FDA Communication Packaging 52

Omnicell

JANUARY 10, 2023

Any future enforcement action," Friedrich said, "must rest on a new statutory provision, a new legislative rule, or a well-developed legal theory that Section 340B precludes the specific conditions at issue here." However, Judge Friedrich's ruling largely in favor of Novartis and United Therapeutics narrows the government's enforcement path.

Documentation 52

Documentation 52