article thumbnail

International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Paul indicated that in 2018, ICMRA introduced an Inspection Reliance Guideline which was adopted by PIC/S ( PICS Inspection Reliance Guidance ).

FDA 97
article thumbnail

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

The FDA Law Blog

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

Dosage 45
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Regulatory Panel Discussion on International Collaboration and Reliance

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Paul indicated that in 2018, ICMRA introduced an Inspection Reliance Guideline which was adopted by PIC/S.

FDA 52
article thumbnail

Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

I personally had a chance to use it myself twice in 2018, after the birth of my son. Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] The first time I used black seed oil was to help support lactation.

Dosage 111
article thumbnail

Lasers for Thyroid Tissue Regeneration

The Thyroid Pharmacist

2] In some cases, the person will become hyperthyroid, and the dosage of their medications will need to be reduced. If they are already taking thyroid medications, they may find themselves overmedicated, and may need to work with their doctors to reduce their dosage of thyroid medications. Published 2018 Nov 4. doi:10.1089/thy.2010.0102;

Dosage 97
article thumbnail

ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done.

article thumbnail

Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

The fourth version was introduced in 2018. For example, some holograms can be designed so that they are only visible behind each pill/capsule cavity on the back of each pack, thereby allowing printing of dosage and marketing information on the area surrounding the pill/capsule recess. percent to as low as 0.20