The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

FDA 69

FDA Research Laboratories Documentation 69

The FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

Documentation 52

Documentation FDA 52

The FDA Law Blog

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.

FDA 64

FDA Packaging Documentation 64

The FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). As part of the pilot program, FDA included a Test Plan. By Adrienne R.

FDA 72

FDA Documentation Communication 72

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

Insurance 104

Insurance Insurance Coverage FDA Documentation 104

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

ISPE

SEPTEMBER 15, 2022

The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments. 12 of February 2020 again received 2,000 comments from public consultation.

Documentation 97

Documentation FDA 97

ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Phillips Professional Achievement Award in 2017 , an award that honors an ISPE Member’s significant lifetime contribution to the industry, not just ISPE.

Documentation 98

Documentation FDA 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% However, the FDA's approval of Lumakras for metastatic non-small cell lung cancer in May last year has a global analyst consensus sales forecast of $336m for this year, according to GlobalData’s Drugs Database. Amgen reported only a marginal 2.2% YoY revenue growth to $26.0bn last year.

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

DECEMBER 28, 2022

These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. She joined NSF in 2017. Preparing for acquisition means preparing for this due diligence investigation to maximise your value and attractiveness.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation FDA Hospitals Dosage 97

Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs. However, not all accelerated approvals for Keytruda have been successfully converted into full approvals.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. They show that England was sixth and Scotland tenth out of 13 countries when ranked according to the percentage of new medicines made available to patients.

Documentation 98

Documentation FDA 98

ISPE

SEPTEMBER 21, 2023

This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

Documentation 98

Documentation FDA 98

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

FDA 59

FDA Documentation 59

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Problem Identification. Root Cause Identification.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

DECEMBER 6, 2022

We’re trying to register lifesaving therapies, but we have to collect the data manually, and often the FDA and EMA inspectors have to visit trial sites to validate the data. He calls out a particular opportunity in the United Kingdom, where COVID-19 and other factors have reduced patient access to clinical trials by 44% since 2017.

Data Entry 98

Data Entry Communication Hospitals Documentation 98

Impact Pharmaceutical Services

APRIL 27, 2023

In addition, the OPEN Act, introduced in 2017, can extend the exclusivity period of a previously approved drug by another six months. Once the designation request has been submitted to the FDA, it is reviewed by the OOPD , which determines if all criteria for ODD approval have been met.

Documentation 52

Documentation FDA 52

The Checkup by Singlecare

OCTOBER 9, 2024

Dupixent (dupilumab) is a brand-name monoclonal antibody drug that is approved by the Food and Drug Administration (FDA) to treat a variety of conditions. Its first approval was in 2017 for atopic dermatitis (eczema). Most only issue coverage for treatments approved by the FDA.

Insurance 52

Insurance Labelling Insurance Coverage Specialty Pharmacies 52

Pharmaceutical Technology

JUNE 30, 2022

In 2017 Oximio began providing dedicated local clinical trial support from its depot in Tbilisi as well as its courier fleet. Global inflation and the increased cost of petrol are also influencing the cost of multinational airfreight, making shipments from the EU and US more expensive than a distribution from a local depot. Expert partners.

Documentation 52

Documentation FDA 52

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. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].

Documentation 98

Documentation Compounding Immunization FDA 98

PharmaShots

JUNE 14, 2023

In Sep 2022, Konica’s Chiropractic Straight Arm (CSA) system received the US FDA’s approval as an X-ray technology allowing diagnosis through visualization of the anatomy. In Jul 2022, DiaSorin’s Liaison MeMed BV test received the US FDA’s approval for its commercial launch across the US.

FDA 56

FDA Hospitals Documentation Patient Care 56

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Published 19 January 2017. 30 June 2016. link] 6 BBC News. link] 7 He, J., Cai, and X.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). These media fill process simulations also serve to evaluate the aseptic technique used during operator interventions.

Documentation 52

Documentation Labelling FDA 52

ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2017. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel.

Packaging 52

Packaging Documentation Communication Data Entry 52

ISPE

JANUARY 11, 2023

5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package. 11 (2017): 36–46.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 9 In 2015, the FDA published a guidance manual 10 that provided questions for inspections, including: Is the air flow in critical areas unidirectional when delivered to the point of use? 2 (2017): 44–46. m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

The FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The purpose of this program is to reduce the volume of reports that a manufacturer needs to submit to FDA and to “make malfunction event trends more readily apparent.”.

FDA 59

FDA Documentation 59

The FDA Law Blog

JANUARY 4, 2023

When FDA published its draft guidance on payor communications in 2017, it seemed revolutionary – introducing the concept of pre-approval information exchange for wholly unapproved products. FDA had put industry in a quandary.

Communication 64

Communication FDA Labelling Documentation 64

The Checkup by Singlecare

JULY 9, 2024

It’s also approved by the Food and Drug Administration (FDA) to treat schizophrenia. Adults, adolescents, and children 10 years and older Adults, adolescents, and children 7 years and older Latuda vs. lithium: Conditions treated Through rigorous clinical trials and documentation, the FDA approves medications for very specific uses.

Insurance 80

Insurance Dosage Labelling FDA 80

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020. by the end of 2023).

FDA 59

FDA Documentation Labelling 59

The Thyroid Pharmacist

JULY 14, 2023

I’m excited to report that since the initial publication of this article in 2017, various individuals and companies have created more accessible, direct-to-consumer devices to provide red light therapy; most of them use LEDs instead of lasers. This Class II medical device is FDA-cleared and meant to target all kinds of pain.

Dosage 98

Dosage FDA Immunization Documentation 98

The FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The announcement in the Unified Agenda of a planned NPRM is the most concrete evidence that FDA is moving forward with this plan. Javitt & McKenzie E. So far, all of these efforts have been fruitless.

FDA 56

FDA Documentation 56

pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. 08.30 – 12.30.

Packaging 52

Packaging FDA Documentation Vaccines 52

ISPE

JULY 5, 2023

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52