Blog Category: Biopharma

Labeling Requirements for Prescription Drugs

March 24, 2021
Digital Health

Under FDA there are more than 150 labeling resources that are present for labeling prescription drugs. FDA has approved about 50+ guidances to be used while labelling cartons and containers containing...

Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

March 17, 2020
Biopharma

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements...

FAMHP: New Legislative Measures for Unavailable Medicines

March 5, 2020
Biopharma

This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages was...

TGA Issues New Guidance for TGO 101 (Standard for Tablets, Capsules and Pills)

March 4, 2020
Biopharma

The new guidance helps sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring...

Brazil – General Provisions for Stability Studies of Active Pharmaceuticals and Medicines

February 26, 2020
Biopharma

ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stability studies of active pharmaceutical ingredients (IFAs), and of new, innovative, generic, similar,...

IMDRF Offers Final Clinical Guidelines

November 21, 2019
Standards

The International Medical Device Regulators Forum (IMDRF) released three final documents covering clinical evaluation of medical devices, in vitro diagnostics and software as medical device products;...