Generic Drugs Life Science Marketing Regulation 
Pharma in Brief
AUGUST 9, 2021
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,
Pharma in Brief
FEBRUARY 8, 2024
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
World of DTC Marketing
JUNE 22, 2022
Between 2019 and 2021, Alphabet’s venture-capital arms, Google Ventures, and Gradient Ventures, and its private-equity unit, CapitalG, made about 100 deals, a quarter of Alphabet’s combined total, in life sciences and health care. Then there is the cost of generic drugs.
Pharma in Brief
NOVEMBER 5, 2023
201/96 under the Ontario Drug Benefit Act ( ODBA Regulations ). 935 under the Drug Interchangeability and Dispensing Fee Act ( DIDFA Regulations ). In both Regulations, the new exception would apply where the drug product is “not a new drug as defined in the Food and Drug Regulations ”.
FDA Law Blog
MARCH 6, 2024
John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What?
Delveinsight
FEBRUARY 5, 2021
According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.
Pharmaceutical Technology
NOVEMBER 29, 2022
The drug is also known for its illegal recreational use. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Fox Foundation gave Sanacora a $2 million grant to study the drug’s use for depression in patients with Parkinson’s disease.
Expert insights. Personalized for you.
98 
Let's personalize your content