The FDA Law Blog

MARCH 12, 2024

As we explained in September 2023 , then again in November 2023 , the FTC has intervened in the matter and asked 10 drug companies (really 8 given common ownerships of some of the relevant companies) to delist about 100 patents from the Orange Book that mainly cover the device constituent of a drug/device combination product.

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Dosage FDA 59

ISPE

MARCH 16, 2023

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

The FDA Law Blog

JULY 31, 2023

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. codified at 21 C.F.R. b)(5)(ii)).

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

Blog: Ask a Student Pharmacist

AUGUST 23, 2023

Evgenyi Shalaev, PhD kmjames Wed, 08/23/2023 - 15:55 Expand all + Biography Dr. Evgenyi Shalaev's research efforts are focused on applications of physical chemical principles to drug development and manufacturing, covering a broad range of pharmaceutical R&D such as pre-formulation and formulation development for immediate and controlled release dosage (..)

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Dosage Vaccines 52

The FDA Law Blog

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R. covering ANDA Suitability Petitions.

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FDA Dosage 59

The FDA Law Blog

APRIL 8, 2024

In addition, DEA apportions individual manufacturing quota to API manufacturers and procurement quotas to dosage form manufacturers, which also limits how much each company can manufacture. For example, DEA and FDA jointly acknowledged in an August 1, 2023 letter that there have been ongoing shortages of various stimulant medications (e.g.,

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FDA Hospitals Dosage Controlled Substances 59

The Happy PharmD

APRIL 26, 2023

I decided to calculate the dosage quickly. A 5ml dosage contains 1.8g Or maybe there might be a different dosage of what you (the resident) want. It was available at a dosage of 0.5mg/5 ml. Writing the dosage as a percentage. In February 2023 she had her next to last refill of the prescription filled.

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Dosage Hospitals Prescription Filling Prescription Interpretation 52

The FDA Law Blog

AUGUST 14, 2023

Other interesting datapoints from her presentation: For the period from FY2000 to May of 2023, the percentages of drug manufacturing inspections with OAI classifications was lower in China (about 5% of inspections) than in the United States (8%). facility inspections are approaching traditional levels.

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FDA Dosage Compounding 52

ISPE

DECEMBER 13, 2022

iSpeak Blog. The second day’s keynote will feature Emily Craven from Boston Scientific and focus on the growing opportunity to optimize sterilization technology for active pharmaceutical ingredients (API) that is used to formulate sterile dosage forms and how the current supply chain constraints will welcome innovation in this area.

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Dosage FDA 52

ISPE

FEBRUARY 7, 2023

For the latter two, some medications can be combined for cardiovascular treatment with less frequent dosages, which helps ensure older patients who may struggle more with maintaining a drug taking schedule receive the medications needed to manage the condition. 2023 ISPE Facilities of the Future Conference Prefabrication can also help.

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Vaccines Dosage Hospitals 88

The FDA Law Blog

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

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FDA Communication Dosage 105

Roots Analysis

OCTOBER 5, 2023

Specifically, in case of the pharmaceutical / medical sector, polymers have been used as excipients in formulations (binders, viscosity enhancers and taste masking agents), packaging of dosage forms and coating material for medical devices. Conclusion Polymers, with their wide array of applications, have a major impact on our day-to-day life.

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Packaging Dosage Vaccines 40

The FDA Law Blog

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

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Dosage 59

The Luxe Pharmacist

JANUARY 30, 2023

As many of you know I’ve been on a bit of a health kick since the end of October, so I’m not necessarily creating new resolutions for 2023 when it comes to health. Because Just Thrive is such a potent product, many users feel a difference in just two to three dosages. Sexy right? But hey someone has to talk about it!

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Immunization Customer Service Dosage 98

The Thyroid Pharmacist

DECEMBER 29, 2023

I can’t believe that it’s been over 10 years since I started the thyroidpharmacist.com blog in 2013, and now 2023 is almost over. 2023 was probably the second or third most creative/productive year for me in the last decade, in terms of creating healing resources and just overall intensity (I’ll share more details below).

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Adverse Reactions Immunization Dosage 54

ISPE

OCTOBER 27, 2022

iSpeak Blog. It is a great honour and pleasure for me as the 2022-2023 ISPE Board Past Chair and Chair of the 2023 ISPE Aseptic Conference Program Committee to give you a first glimpse at the program and of the information and knowledge that will be shared at the conference. 2023 ISPE Aseptic Conference. Trudy Patterson.

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Dosage Vaccines FDA Documentation 98

ISPE

MARCH 9, 2023

Date: Thursday, 23 March 2023 Time: 0900 – 1200 ET | 1400-1700 CET Price: Free for ISPE members This event will be an interactive virtual event leveraging the Remo online event platform. There will be a kick off the event with an overview of the ISPE Communities of Practice (CoPs).

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Packaging Dosage 52

The FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). Complaint ¶ 57. (The

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Controlled Substances Documentation Dosage Prescription Filling 139

The FDA Law Blog

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., Vanda Pharmaceuticals, Inc. MJM-22-977 (Dist.

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Dosage 59

The Thyroid Pharmacist

JUNE 30, 2023

Many times, people have been able to eliminate their symptoms and reduce their dosages of medications. I hope that with the information I share in my books and on this blog, you will be able to get yourself into remission more quickly and efficiently. Published 2023 Mar 31. Published 2018 Sep 21. Mediterr J Rheumatol.

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Compounding Immunization Compounding Pharmacies Insurance Coverage 98

The FDA Law Blog

JANUARY 18, 2023

By Faraz Siddiqui — Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA). The memorandum also introduced the Program’s spanking new logo.

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Dosage 59

The FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. 16 June 2023) Eliquis Novartis D.N.J. (1

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Dosage 64

The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

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FDA Controlled Substances Chemotherapy Compounding 69

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 ). To be considered by FDA, comments must be submitted by January 3, 2023. Importantly, to be deemed a single site, a multiple-facility operation must be listed with the agency under one “FDA establishment identifier” (FEI).

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FDA Packaging Labelling Dosage 52

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. 7 June 2023. iSpeak blog. Accessed 14 April 2023. Updated January 2023.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

Roots Analysis

JANUARY 24, 2024

The market landscape is well-fragmented, featuring the presence of small, mid-sized, large, and very large companies, which claim to have the required expertise in continuous small molecule API manufacturing and Finished Dosage Form (FDF) manufacturing.

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Pharmaceutical Companies Pharmaceutical Companies Dosage Vaccines 40

ISPE

SEPTEMBER 8, 2023

The survey launched in April 2023 and is still open ! Results will be presented at meetings, summarized in blogs, and eventually issued in a report. As of April 2023, there are eight countries involved: Australia, Brazil, Canada, Israel, Singapore, Switzerland, the UK, and the US 16.

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FDA Dosage Documentation Communication 52

ISPE

FEBRUARY 15, 2023

ISPE Launches Enabling Global Pharma Innovation: Delivering for Patients Trudy Patterson Wed, 02/15/2023 - 11:38 iSpeak Blog iSpeak ISPE Launches Enabling Global Pharma Innovation: Delivering for Patients Christopher John Potter, PhD Roger Nosal 15 February 2023 ISPE is launching a new program, Enabling Global Pharma Innovation: Delivering for Patients (..)

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Dosage FDA 95

The FDA Law Blog

MAY 5, 2024

29, 2023). FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. Unlike its 2016 analysis, FDA’s/HHS’ 2023 analysis considers marijuana to have a currently accepted medical use in treatment in the U.S. Letter to U.S.

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Controlled Substances FDA Chemotherapy Dosage 95