Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. ’s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations 40

Regulations Pharmaceuticals Production Compliance 40

Agency IQ

MAY 3, 2024

A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

AUGUST 2, 2024

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The proposed rule would include requirements for Patient Medication Information development and distribution.

FDA 40

FDA Science Regulations Production 40

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Download your copy today. In this complimentary webinar , Mel B. Watch the webinar.

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

Agency IQ

JUNE 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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FDA Science Regulations Production 40