Compliance, FDA Approval and Packaging

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog: Biosimilars

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

Government

Government Small Molecule FDA Approval Regulations

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

FDA

FDA Drugs FDA Approval Packaging

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Six years later with the reauthorization of several FDA-industry user fee programs in 2012, Congress took the opportunity to set a series of policy changes into motion. However, the proposed rule sat in limbo for years without ever being finalized.

FDA

FDA Regulations Production Packaging

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. In other words, it’s up to the Importer how to structure the PIR requests and shipments.

FDA Approval

FDA Approval FDA Science Drugs

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” MoCRA amends the FD&C Act by expanding the FDA’s authority over cosmetics, adding new definitions and requirements for manufacturers and importers of cosmetics.

Production

Production FDA Compliance Packaging

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

Government

Government Vaccine Production Licensing

Article FDA Thank You AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

Agency IQ

MAY 31, 2024

sensitivity and specificity) – including colonoscopy procedures and an FDA-approved stool-based test ( Cologuard ) – but comparatively low uptake, given the prevalence of CRC in the population. Notably, CRC screening methods are currently available and have generally high performance (i.e.,

FDA

FDA Laboratories Compliance Packaging

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Oncology and Hematology. Regulatory. Regulatory.

Production

Production International Licensing Licensing

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

Agency IQ

DECEMBER 1, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list. Comments on the proposal closed on July 19.

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

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list. Comments on the proposal closed on July 19.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations

Regulations FDA Science Production

Mixson Somewhat Mixed, But We’ll Take It

Drug & Device Law

NOVEMBER 1, 2022

Punitive damages also failed as a matter of law under Arizona’s compliance defense. It is undisputed here that the filter received FDA approval. First, since “clearance” was right there in the statute, arguments that clearance was not approval failed. quoting Ariz. 12-689(A)(1)). Plaintiff’s response was puny.

Testimonials

Testimonials FDA FDA Approval Packaging

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. Strike one.

Testimonials

Testimonials FDA Drugs Vaccine

Another Favorable Post-Albrecht MDL Preemption Decision

Drug & Device Law

SEPTEMBER 12, 2022

Both propositions are well recognized, but Pfaff ties them together in one neat package. When the FDA approved [defendant’s] supplemental CBE in 2011, [defendant] was not aware of the impossibility of adding a suicidality warning under federal law.

FDA

FDA FDA Approval Regulations International

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

FDA Approval

FDA Approval FDA Regulations Production

Drug Discovery Digest

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

Trending Sources

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

Article FDA Thank You AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

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

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

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Mixson Somewhat Mixed, But We’ll Take It

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Another Favorable Post-Albrecht MDL Preemption Decision

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

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