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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog: Biosimilars

JUNE 8, 2023

Soon after, the Agency announced beginning on March 27, 2023, the FDA generic drug program would resume in-person FTF meetings, but caveated that the in-person FTF meeting option would only be available for pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.

FDA

FDA Biosimilars Production Government

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

Production

Production Clinical Trials FDA Drugs

MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

FDA Law Blog: Biosimilars

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.

FDA

FDA Drugs Production

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

These products are devices as defined in section 201(h) (1) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act, including when the manufacturer of these products is a laboratory.

Laboratories

Laboratories FDA Regulations Production

No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. Like in the multitude of Orphan Drug Act cases preceding this one, Jazz alleges that FDA’s authority under the Orphan Drug Act was limited by the statutory language.

FDA

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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. Opinion at 17. contradicts the plain text of the statute and therefore must be set aside.” . ; see also 42 U.S.C.

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An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

FDA Law Blog: Biosimilars

JUNE 7, 2023

Kirschenbaum — The Inflation Reduction Act’s price negotiation program for drugs covered under Medicare Parts B and D (“Negotiation Program”) has been challenged in federal court. to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value.

Government

Government Drugs Compliance Production

Apples to apples: Stelara biosimilars and the fight for market share

BioPharma Drive: Drug Pricing

JULY 21, 2025

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). What is the impact of vertical integration, the IRA and other factors on biosimilar adoption?

Biosimilars

Biosimilars Marketing FDA Therapies

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority A List.

FDA

FDA Science Biosimilars Clinical Trials

FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

FDA

FDA Regulations Production Drugs

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

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA

FDA Science Biosimilars Regulations

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog: Biosimilars

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

Regulations

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. Food and Drug Administration (FDA). About Pfizer: Breakthroughs That Change Patients’ Lives.

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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) recommendation that the Drug Enforcement Administration (“DEA”) reschedule cannabis federally from schedule I to schedule III would lead an outsider to conclude that commenters are referring to different substances. Letter to U.S.

Regulations

Regulations Production Drugs FDA Approval

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. RE47,739 for Ibrance by more than four years until March 2027. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2021.

Vaccine

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Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase Out

FDA Law Blog: Biosimilars

JULY 23, 2025

Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. 3 in food prior to the previously announced 2027 deadline.

FDA Approval

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Looking for Clues about FDA Under RFK Jr.

FDA Law Blog: Biosimilars

JANUARY 29, 2025

Aside from his many high profile claims about vaccines, what he perceives as corruption at FDA, and his promise to go wild on health, Kennedys specific policy preferences about how FDA should administer its day-to-day oversight of drugs, medical devices, food, dietary supplements, cosmetics, or tobacco have not been publicly detailed.

FDA

FDA Vaccine Disease Drugs

Update on CDER, CBER, and CDRH Meetings with Industry

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

Trending Sources

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

Proposed LDT Rule Raises Many Questions but Provides Few Answers

No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

Apples to apples: Stelara biosimilars and the fight for market share

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

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

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

Article EMA Thank You What we expect European regulators to do in August and September 2024

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase Out

Looking for Clues about FDA Under RFK Jr.

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