FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2. Draft Guidance III.B.2(e)

FDA 52

FDA FDA Approval Licensing Licensing 52

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA 40

FDA Pharmacy Drugs Production 40

The Pharma Data

NOVEMBER 16, 2020

The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices. No Dilution Required at Vaccination Site: The vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians’ offices.

Vaccine 52

Vaccine FDA Clinical Trials Pharmacy 52

The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. CHPA considered the original studies to be sound and instead found issues with the newer studies.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

Agency IQ

JANUARY 4, 2024

Citizen petitions have raised the alarm regarding benzene in recent years, leading to FDA action Valisure, an analytical pharmacy that first alerted the FDA to concerns associated with nitrosamine impurities , recently set its sights on benzene impurities.

FDA 40

FDA Production Laboratories Drugs 40

The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Virus 40

Virus Trials Clinical Trials Production 40

Policy Prescription

OCTOBER 22, 2024

Harvard doctors and public health experts recommend using the website PharmacyChecker.com to find international online pharmacies to order more affordable prescription drugs for personal importation when domestic savings strategies fail. Pharmacy discount cards and coupons are freely accessible on sites like GoodRx and RxSaver.

Online Pharmacies 113

Online Pharmacies Pharmacy Drugs FDA Approval 113

Policy Prescription

FEBRUARY 9, 2022

Mark Cuban’s new online pharmacy venture – the Mark Cuban Cost Plus Drug Company (“Cost Plus Drug”) – will not help overcome the biggest obstacle to drug affordability in America, which is drug company monopolies on patented brand name prescription drugs. That’s even cheaper than foreign online pharmacy prices , including in India. .

Pharmacy 52

Pharmacy Online Pharmacies Pharmaceuticals Drugs 52

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient. Source link.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 52

FDA Law Blog: Biosimilars

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

Pharmacy 105

Pharmacy FDA FDA Approval Production 105

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science 40

Science FDA Production Packaging 40

The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). AZ’ Tagrisso first to win MHRA approval under Project Orbis ( PharmaTimes ) ( Pink Sheet ) ( MHRA ).

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. REGN-COV2 (casirivimab and imdevimab) FDA Approval History. Source: Regeneron. Source link.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

TAB, CAP, ML, EA), drug type (prescription or OTC), base date AMP, therapeutic equivalent code, line extension indicator, 5i indicator, 5i route of administration (if applicable), FDA approval date, FDA application number or OTC monograph citation (if applicable), market date, and covered outpatient drug status.

Drugs 59

Drugs Regulations International Production 59

The Pharma Data

APRIL 4, 2023

Both tablet strengths are available via prescription through existing specialty pharmacy networks. Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019.To ERLEADA ® received U.S.

Specialty Pharmacies 40

Specialty Pharmacies FDA Approval Pharmaceutical Companies Pharmacy 40

Agency IQ

JUNE 16, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. What ever happened to that thing?

FDA 40

FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc.

Production 40

Production Trials FDA FDA Approval 40

The Pharma Data

JANUARY 24, 2021

The Company owns 80% of Pharmadrug GmbH, a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the EU.

FDA 52

FDA Drugs Clinical Development Disease 52

Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. By contrast, a biosimilar product is only “highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency.”

Science 40

Science Biosimilars FDA Production 40

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 29, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

Pharmacy 52

Pharmacy Doctors Production Therapies 52

National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

Opioid use disorder is treatable with one of the three FDA approved medications, buprenorphine, methadone, and naltrexone, but currently only 18% of people who could benefit from these drugs receive them. People in rural communities may have particular difficulty accessing care. Most of the fatal overdoses each year involve opioids.

Science 122

Science FDA Approval Treatment Research 122

Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval 52

FDA Approval FDA Production Treatment 52

Agency IQ

DECEMBER 1, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40

National Institute on Drug Abuse: Nora's Blog

JANUARY 6, 2025

8 Currently in the United States, methadone is only available from specialized opioid treatment centers, but studies piloting access through pharmacies have shown promise. Risk of dying was similarly low for both groups. OUD medications also need to be accessible to people with SUD in jails and prisons.

Treatment 111

Treatment Science Drugs Research 111

FDA Law Blog: Biosimilars

OCTOBER 29, 2023

With this guidance, the Departments decided to reference the 2019 HRSA Guideline rather than the FDA Birth Control Guide for the range of identified categories of contraception (FAQ Part 54, Q2), stating that plans and issuers must cover without cost sharing at least one form of contraception in each category.

FDA Approval 45

FDA Approval FDA Production Pharmacy 45

Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs.

FDA 40

FDA Doctors Testimonials Regulations 40

The Pharma Data

JULY 29, 2021

Under the EUA, inpatient pharmacies in the U.S. See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Serious Side Effects.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

The Premier Consulting Blog

NOVEMBER 12, 2024

For drug developers the 505(b)(2) pathway presents an expedited pathway to FDA approval. In our experience, the conversation on 505(b)(2) pathways commonly focuses on predicate data or bridging strategies to accelerate FDA approval but lacks dialogue on the needs of US payers. This is standard formulary policy language.

Marketing 52

Marketing FDA Approval FDA Drugs 52