FDA Law Blog: Biosimilars

APRIL 1, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails.

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FDA Law Blog: Biosimilars

NOVEMBER 14, 2024

How much of that critique could be translated into an effective regulatory (or deregulatory) agenda in light of constraints on FDA’s authority and other factors will be the subject of another blog posting, but the power of the bully pulpit should not be underestimated.

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Alta Sciences

JUNE 26, 2025

Stay connected linkedin youtube Footer Solutions Preclinical Services Clinical Services Manufacturing and Analytical Services Bioanalytical Services Research Support Services Development Programs News & Events Altasciences Events Press Releases Altasciences in the News Press Kit Resource Center The Altascientist Webinars/Podcasts Newsletters Scientific (..)

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FDA Law Blog: Biosimilars

JULY 2, 2025

Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) seeks to add an experienced regulatory expert to our strong and busy team of non-attorney regulatory experts. Our team assists clients with a wide variety of quality and manufacturing regulatory topics for drugs and biologics.

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FDA Law Blog: Biosimilars

MARCH 24, 2025

By Larry K. Houck In August 2023, the U.S. Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III.

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FDA Law Blog: Biosimilars

NOVEMBER 19, 2024

Schwartz — Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. By John W.M. Claud & Mark I. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and Human Services.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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FDA Law Blog: Biosimilars

MAY 4, 2025

By Larry K. Houck Drug Enforcement Administration (DEA) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. Even more scarce are DEA civil settlements with non-registrants. (By By my count there have been only ten since 2000). When one comes along, it is worthwhile to sit up and take notice.

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Alta Sciences

JUNE 26, 2025

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FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

By Jennifer D. Newberger & Jeffrey N. Gibbs — On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr., for Secretary of Health and Human Services (HHS).

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FDA Law Blog: Biosimilars

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model.

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FDA Law Blog: Biosimilars

JUNE 1, 2025

By Charles D. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

By Richard A. Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025.

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FDA Law Blog: Biosimilars

DECEMBER 9, 2024

On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. See our post on this rule here.)

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FDA Law Blog: Biosimilars

OCTOBER 20, 2024

By Larry K. Houck — Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead! Bring out your dead!” in the 1975 comedy classic, Monty Python and the Holy Grail. The Drug Enforcement Administration (“DEA”) would do well to update that phrase as “Bring out your meds! Bring out your meds!”

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2024

By Jennifer D. Newberger — Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product.

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FDA Law Blog: Biosimilars

APRIL 3, 2025

By John W.M. Claud & JP Ellison Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence.

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FDA Law Blog: Biosimilars

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. 105288 (Dec.

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FDA Law Blog: Biosimilars

MAY 27, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. These are scheduled to take place in several cities on both coasts in June and July (Link here). This tour to engage with pharmaceutical and biotech CEOs is unprecedented.

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FDA Law Blog: Biosimilars

JUNE 30, 2025

By Larry K. Houck — A memorable Florida Orange Growers’ television ad campaign in the late 1970s proclaimed that “Orange juice from Florida isn’t just for breakfast anymore.”

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FDA Law Blog: Biosimilars

MAY 19, 2025

By Larry K. Houck Last month the U.S.

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FDA Law Blog: Biosimilars

MAY 23, 2025

One examples of this is with robotic surgical devices, about which we have previously blogged ( here ). Over the last decade or so CDRH has moved away from granting clearance/authorization for new tools, instead forcing sponsors to get new clearances and authorizations for specific indications (e.g.,

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

By Andrew J. 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.

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FDA Law Blog: Biosimilars

JUNE 2, 2025

By Steven J. Gonzalez & Allyson B. Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

By Sarah Wicks & Anne K. Walsh The recent and drastic Reduction In Force (RIF) at the U. Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large.

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FDA Law Blog: Biosimilars

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here.

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FDA Law Blog: Biosimilars

MAY 15, 2025

By John W.M. Claud & Deborah L. Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own.

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FDA Law Blog: Biosimilars

APRIL 8, 2025

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd.

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FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

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FDA Law Blog: Biosimilars

APRIL 14, 2025

As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards. The ASCA pilot program concluded in 2023 after seven (7) years based on data demonstrating the pilots objectives were met or surpassed.

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FDA Law Blog: Biosimilars

JULY 13, 2025

By Charles D. Snow — On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025.

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FDA Law Blog: Biosimilars

MAY 21, 2025

By Dara Katcher Levy On May 21, FDA announced enhancements to the Section 804 import program (SIP). Section 804 of the Federal Food, Drug, and Cosmetic Act provides a pathway for certain prescription drug imports from Canada.

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FDA Law Blog: Biosimilars

MARCH 31, 2025

Expect another blog from us in the coming days that will provide a more detailed discussion of what this decision means for healthcare practitioners, the laboratory industry, and the public. Laposata were represented by a team at Hyman, Phelps & McNamara, P.C.,

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FDA Law Blog: Biosimilars

JUNE 26, 2025

Karst — Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced ( here and here ) the release of a report, titled “ Assessment of the Impact of Settlements ,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and biosimilar biological products.

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

By Allyson B. Mullen & Jeffrey N. Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week.

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