The Pharma Data

NOVEMBER 5, 2020

Sussman has also had leadership experience in industry as the founder and vice president of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc. Most recently, Holland served as Global Head of licensing at Lonza AG. from 1993 to 1995. FAST BioMedical – Privately-held FAST named Jim Dillon to its board of directors.

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Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. A startup that makes such a spray has gained an EPA license to sell its product to customers in the consumer, commercial, and healthcare sectors. Read it on our website here. The man was in Hong Kong for kidney treatment.

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Virus Hospitals Production Regulations 68

Agency IQ

JUNE 2, 2023

However, only licensed blood establishments would be required to submit PMI to FDA for approval.” It’s worth noting that FDA’s definition of approval includes efficacy supplements, and not just the date of first approval.

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The Pharma Data

MARCH 8, 2021

Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. About Ridgeback Biotherapeutics.

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Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. The Coke Ovens: Pushing, Quenching, and Battery Stacks NESHAP, subpart CCCCC, was promulgated pursuant to section 112(d) of the CAA on April 14, 2003.

Regulations 40

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New Drug Approvals

JULY 10, 2023

While zavegepant is a highly soluble molecule, its bioavailability characteristics may render it challenging to prepare the drug in an oral dosage form. Click here to purchase.

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Clinical Trials Treatment FDA Trials 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. This must be a U.S.-based

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. Rescheduling would eliminate a tax burden on cannabis companies, allowing licensed companies to expand investments into state programs and focus on public health in collaboration with law enforcement efforts.

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Regulations Production FDA Approval Drugs 57

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

MAY 26, 2023

644 (2003), but not to Pike. You never need an authorization from a licensed professional to buy pork or fireworks. In that Fourth Circuit case we mentioned above , the court looked to Healy (which knocked out a Connecticut wholesale beer pricing law) and Pharmaceutical Research & Manufacturers of America v. Walsh , 538 U.S.

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Regulations Production FDA FDA Approval 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

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Testimonials Doctors Production Laboratories 59

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. The Complaint nowhere alleges that either the persons allegedly targeted or the persons purportedly targeting their “wild conspiracy theories” have any connection to Texas, which leaves us wondering how the Texas Deceptive Trade Practices Act (“DTPA”) could possibly apply. See Henry Schein, Inc. Stromboe , 102 S.W.3d

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Vaccine FDA FDA Approval Production 59

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 2003), aff’d , 810 N.Y.S.2d As a result, appellee was prohibited by federal law from employing either of these [alternatives].

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