Registration of Generic & Comparative Drugs in Brazil
Before reaching the Brazilian consumer market, it is necessary that a drug has its quality, safety, and therapeutic efficacy evaluated by the National Health Surveillance Agency (ANVISA).
Brazil’s Anvisa approves new Remdesivir indication for Covid-19
The new indication is for adult patients who do not require supplemental oxygen and who are at risk of progressing to a severe case.
Brazil’s Fiocruz concludes genetic sequencing of monkeypox virus detected in Rio de Janeiro
Fiocruz, through its Genomics Network, has concluded the genetic sequencing of the monkeypox virus (MPXV) collected from a sample coming from Rio de Janeiro.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
China’s NMPA Releases draft on the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
Monkeypox: Anvisa guides health services on case management
The National Health Surveillance Agency (Anvisa) provides guidance on prevention and mitigation measures for Monkeypox in hospitals, clinics and other health services that provide care to suspected and confirmed cases of the disease.
China’s NMPA: Local Agent in China for Foreign Pharmaceutical and Medical Device Companies
A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations.
Monkeypox Reaches Brazil: Anvisa suggests mask and isolation to postpone arrival of smallpox
The National Health Surveillance Agency (Anvisa) is asking for reinforcement of non-pharmacological measures, such as distancing, use of masks and frequent hand hygiene, in airports and aircrafts, to delay the entry of the monkey pox virus into Brazil.
THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
THE US-FDA publishes product-specific guidances (PSGs) to facilitate generic drug development
On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product
The US- FDA Launches New Accelerating Rare disease Cures (ARC) Program
On May 2022, the US-FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the new Accelerating Rare disease Cures (ARC) Program.
THE US-FDA Announces Draft Guidance on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On May 5th, 2022, the FDA announced the availability of a draft guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.