Biosimilars and Testimonials - Drug Discovery Digest

HP&M Counsel John Claud Provides Testimony to House Subcommittee on FDA Foreign Inspections

FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

Mr. Claud was joined in his testimony by Mary Denigan-Macauley , a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. Mr. Claud closed his testimony echoing that sentiment. Mr. Thakur is a public health advocate and a former executive at Ranbaxy Laboratories in India.

Testimonials

Testimonials FDA International Laboratories

Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Parties will have ninety minutes to present the testimony of their witness. Prehearing Ruling (Dec. 4, 2024), at 1.

Testimonials

Testimonials Regulations Drugs

GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog: Biosimilars

MARCH 29, 2024

That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program.

Clinical Research

Clinical Research FDA Research Clinical Trials

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

MARCH 1, 2024

For example, statutorily, the prescription drug user fee program (PDUFA) has a statutory cap of total carryover for operating reserves of 14 weeks, while the biosimilar user fee program (BsUFA) had a goal of bringing the carryover balance down to “no greater than 21 weeks of operating reserves” by the end of the 2022 fiscal year.

Government

Government FDA Biosimilars Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

JUNE 29, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to include devices.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to include devices.

FDA

FDA Science Regulations Production

Stand by Your Case? Without Standing, Supreme Court Precedent Means You’ll Have More Bad Times than Good

FDA Law Blog: Biosimilars

JULY 21, 2024

In alleging that antibiotic use was a public health problem that FDA should regulate, the plaintiffs offered several testimonials from ostensibly affected people. Alliance for Nurses started as a Citizen’s Petition back in 2016, making its way to District Court when FDA took no action.

Nurses

Nurses FDA Testimonials Doctors

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony.

Drugs

Drugs FDA Hospitals Government

When the Attorney General Talks (Cannabis), People Listen

FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. AG Garland concluded that he anticipates DOJ’s cannabis policy will be consistent with what he said during his confirmation in that “it will be very close” to the Cole Memorandum. 1, 2023 ( 02:38:46 ).

Testimonials

Testimonials Regulations Compliance Drugs

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to include devices.

FDA

FDA Science Regulations Production

DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Hull A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agencys approach to crediting one experts testimony over that of another expert during an administrative hearing. The hearing involved dueling expert testimony on the pharmacy standard of care in Louisiana from both DEA and the respondent.

Testimonials

Testimonials Pharmacy Government Drugs

Gentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins Monday

FDA Law Blog: Biosimilars

NOVEMBER 26, 2024

No witness testimony will be offered nor received on Monday. The “preliminary hearing,” which will begin Monday, December 2nd at 9:30 a.m. in DEA’s North Courtroom at its headquarters in Arlington, Virginia, will serve to address legal and logistical issues and future dates for the evidentiary hearing on the merits.

Engineering

Engineering Testimonials Drugs

A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law Blog: Biosimilars

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. The concerns raised by PERA are not limited to these industries, however.

Laboratories

Laboratories DNA Testimonials Biosimilars

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. That would leave 19% of staff affected by furloughs. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

FDA

FDA Science Biosimilars Regulations

After a Hiatus, the BLOCKING Act is Back!

FDA Law Blog: Biosimilars

DECEMBER 11, 2024

After all, the BLOCKING Act would significantly alter the ANDA Paragraph IV 180-day exclusivity incentive.

Packaging

Packaging Testimonials Drugs Drug Development

Drug Discovery Digest

HP&M Counsel John Claud Provides Testimony to House Subcommittee on FDA Foreign Inspections

Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

Trending Sources

GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Stand by Your Case? Without Standing, Supreme Court Precedent Means You’ll Have More Bad Times than Good

Does the Drug Shortage White Paper Fall Short?

When the Attorney General Talks (Cannabis), People Listen

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

Gentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins Monday

A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

After a Hiatus, the BLOCKING Act is Back!

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