Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Biologics, controlled substances, and certain other drugs are not eligible for importation.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . The FDA is also looked to by drug regulatory authorities in other countries for its strengths. Far from it.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

The Pharma Data

NOVEMBER 20, 2020

in partnership with BioNTech Manufacturing GmbH. The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. Source: FDA. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Posted: November 2020. More News Resources. Subscribe to our Newsletter.

Vaccination 52

Vaccination Vaccine Cosmetics Production 52

FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. Section II at 2.

Drugs 52

Drugs Production Manufacturing Licensing 52

Intouch Solutions

JUNE 30, 2022

47% of those had made in-game purchases, and 37% had purchased virtual cosmetic items. If major pharmacies like CVS are planning for the metaverse, pharma manufacturers should be fast followers! And 79% of their 3,000 survey respondents said that they had already – not someday! made a purchase inside a metaverse.

Pharmacy 52

Pharmacy Radiology Cosmetics Manufacturing 52

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Q: What is your advice for approaching the regulatory strategy?

Packaging 52

Packaging Packaging Drugs Containment 52

FDA Law Blog

OCTOBER 4, 2021

Karst — In the appellate courts lately, it’s been FDA “ Against the Music.” In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. Earlier this year, the D.C.

Drugs 52

Drugs Marketing Production Cosmetics 52

FDA Law Blog

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 Drugs Manufacturing Production 105

FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false. But we digress.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B). chemotherapy-induced), and pain.

Drugs 69

Drugs FDA Approval Containment Production 69

The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. ” The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. SILVER SPRING, Md. ,

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

FDA Law Blog

SEPTEMBER 5, 2023

Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) or abbreviated new drug application (“ANDA”) under the federal Food, Drug and Cosmetic Act (21 U.S.C. §

Drugs 111

Drugs Cosmetics FDA Approval Licensing 111

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. The FDA approved the drug over a decade ago in September 2009.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

MAY 21, 2024

because it was not the subject of an approved new drug application (“NDA”) nor an abbreviated new drug application (“ANDA”) under the Federal Food, Drug, and Cosmetic Act. In 2016, HHS and DEA determined that marijuana did not have a currently accepted medical use (“CAMU”) in treatment in the U.S. Basis at 63-64.

Drugs 69

Drugs Regulation Licensing Licensing 69

XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

Drugs 69

Drugs Cosmetics Medicine FDA Approval 69

FDA Law Blog

JANUARY 8, 2025

Koblitz Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing.

Production 111

Production Drugs Cosmetics FDA Approval 111

Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

Drugs 61

Drugs FDA Approval Manufacturing Pharmacy 61

Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. to sell drugs that are approved by the FDA or lawful, foreign versions of FDA-approved drugs and require valid prescriptions.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

Pharmacy Checkers

DECEMBER 20, 2019

The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices. Most importantly, Canada and the manufacturers may not cooperate. Why would they do that?

Drugs 73

Drugs FDA Approval Cosmetics Pharmacy 73

Pharmacy Checkers

JANUARY 30, 2020

Here’s what Azar had to say in an HHS press release from 2018: “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. And only if the drug is proven to be the exact same FDA-approved drug.

Drugs 54

Drugs Generic Drugs Cosmetics FDA Approval 54

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. Part J is written in three sections.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

FDA Law Blog

FEBRUARY 12, 2023

Rather than creating its own importation program under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act), the Food and Drug Administration (FDA) used the statute to create a pathway for States and Indian Tribes (“Sponsors”) to develop such programs (called Section 804 Importation Programs, or SIPs).

Pharmacy 97

Pharmacy Drugs FDA Approval Cosmetics 97

FDA Law Blog

JUNE 17, 2021

Schlanger — In October 2020, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a Final Rule (which we summarized here ) that implemented Section 804 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §

Drugs 52

Drugs Cosmetics FDA Approval Manufacturing 52

Pharmacy Checkers

AUGUST 2, 2019

The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act. The second channel of importation, which is separate from the state drug importation programs, would allow drug companies to import lower-cost foreign version of their own FDA-approved drugs.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

FDA Law Blog

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. By Faraz Siddiqui & Alan M. See 21 C.F.R. 251.5; § 251.6(c).

FDA Approval 59

FDA Approval Drugs Manufacturing Compliance 59

FDA Law Blog

JULY 12, 2021

The Order calls on FDA “to reduce the cost of covered products to the American consumer without imposing additional risk to public health and safety, [by working] with States and Indian Tribes that propose to develop section 804 Importation Programs.”

Drugs 52

Drugs Cosmetics Marketing Regulation 52